FCC ID 2AKHI-1017
C2 CryoBalloon Ablation System Controller
by Pentax Medical
Grantee Code: 2AKHI Product Code: 1017
Latest application date: 2017-07-27
FCC ID Device Details
| FCC ID | 2AKHI-1017 |
|---|---|
| Mirrors | fcc.id | gov | fccid.ai |
| Grantee Code | 2AKHI |
| Product Code | 1017 |
| Applicant Business | Pentax Medical 🇺🇸 |
| Related Domains |  pentaxmedical.com |
| Equipment Class | C2 CryoBalloon Ablation System Controller |
| Test Firm | TUV Rheinland of North America Inc. |
Operating Frequencies
| Frequency Range | Application Purpose | Final Action Date |
|---|---|---|
| 13.56 MHz | Original Equipment | 2017-07-27 |
Exhibits
| Document | Type | Available | File |
|---|---|---|---|
| Manual | Users Manual | 2017-09-26 | PDF 972.8 KB |
| Ext | External Photos | 2017-07-27 | PDF 213.3 KB |
| Label | ID Label/Location Info | 2017-07-27 | PDF 202.3 KB |
| Test Setup | Test Setup Photos | 2017-07-27 | PDF 1.1 MB |
| Report | Test Report | 2017-07-27 | PDF 1.2 MB |
| Authorization | Cover Letter(s) | 2017-07-27 | PDF 191.3 KB |
| Confid | Cover Letter(s) | 2017-07-27 | PDF 234.3 KB |
| Int Metadata only | Internal Photos | PDF 558.5 KB | |
| Block Metadata only | Block Diagram | PDF 202.9 KB | |
| Schema Metadata only | Schematics | PDF 1.5 MB | |
| Ops Metadata only | Operational Description | PDF 364.8 KB |
Application Information
| Application ID | zKkf7+A9+WhsycQa4utvIQ== |
|---|---|
| Final Action Date | 2017-07-27 |
| Application Purpose | Original Equipment |
| Applicant FRN | 0026046078 |
| Model | 1017 |
| Frequency Range | 13.56 MHz |
| Equipment Class | DXX - Part 15 Low Power Communication Device Transmitter |
| Device Description | C2 CryoBalloon Ablation System Controller |
| Responsible Party | Gurvinder Singh Nanda, Sr. Director Regulatory and Quality, gurvinder.nanda@pentaxmedical.com , 6507224189 |
| Technical Contact | Gabriel Newell, C2 Therapeutics, gabe@c2therapeutics.com  , (530) 515-8553 |
| Test Firm | David Spencer, TUV Rheinland of North America Inc., dspencer@us.tuv.com  , (925) 249-9123 x2116 |
| TCB Email | fcb@us.tuv.com |
| TCB Scope | A1: Low Power Transmitters below 1 GHz (except Spread Spectrum), Unintentional Radiators, EAS (Part 11) & Consumer ISM devices |
| Short-Term Confidentiality | Yes |
| Short-Term Confidentiality Date | 09/26/2017 |
| Long-Term Confidentiality | Yes |
| Grant Deferral | No |
| Modular Equipment | Does not apply |
| Composite Device | No |
| Composite Part | No |
| Cognitive Radio | No |
| Authorization Waiver | No |
| Authorization Waiver Approved | No |
| Section 5301 Certification | Yes |
| Related OET Knowledge DataBase Inquiry | No |
| Grant Comments | USA federal law restricts this device to sale by or on the order of a physician. |
Applications
| Application ID | Date | Purpose |
|---|---|---|
| zKkf7+A9+WhsycQa4utvIQ== | 2017-07-27 | Original Equipment |
Grants
TCB Grant - Application zKkf7+A9+WhsycQa4utvIQ==
| TCB | GRANT OF EQUIPMENT AUTHORIZATION |
TCB |
| Certification | ||
| Issued Under the Authority of the | ||
| Federal Communications Commission | ||
| By: |
|
TUV Rheinland of North America, Inc. 1279 Quarry Lane Suite A Pleasanton, CA 94566 |
Date of Grant: 07/27/2017 Application Dated: 07/26/2017 |
| Pentax Medical |
| 303 Convention Way |
| STE 1 |
| REDWOOD CITY, CA 94063 |
| Attention: Gurvinder Nanda , Sr. Director Regulatory and Quality |
| NOT TRANSFERABLE |
| EQUIPMENT AUTHORIZATION is hereby issued to the named GRANTEE, and is VALID ONLY for the equipment identified hereon for use under the Commission's Rules and Regulations listed below. |
| FCC IDENTIFIER: | 2AKHI-1017 |
| Name of Grantee: | Pentax Medical |
| Equipment Class: | Part 15 Low Power Communication Device Transmitter |
| Notes: | C2 CryoBalloon Ablation System Controller |
| Grant Notes | FCC Rule Parts | Frequency Range (MHZ) | Output Watts | Frequency Tolerance | Emission Designator |
| 20 | 15C | 13.56 - 13.56 |
| USA federal law restricts this device to sale by or on the order of a physician. |
| 20: | All electrical and mechanical devices employed for spurious radiation suppression, including any modifications made during certification testing, must be incorporated in each unit marketed. |
EAS Grant - Application zKkf7+A9+WhsycQa4utvIQ==
| COPY |
FEDERAL COMMUNICATIONS COMMISSION WASHINGTON, D.C. 20554 GRANT OF EQUIPMENT AUTHORIZATION |
COPY |
| Certification |
|
Pentax Medical 303 Convention Way STE 1 REDWOOD CITY, CA 94063 United States |
Date of Grant: 07/27/2017 Application Dated: 07/26/2017 |
| Attention: Gurvinder Nanda , Sr. Director Regulatory and Quality |
| NOT TRANSFERABLE |
| EQUIPMENT AUTHORIZATION is hereby issued to the named GRANTEE, and is VALID ONLY for the equipment identified hereon for use under the Commission's Rules and Regulations listed below. |
| FCC IDENTIFIER: | 2AKHI-1017 |
| Name of Grantee: | Pentax Medical |
| Equipment Class: | Part 15 Low Power Communication Device Transmitter |
| Notes: | C2 CryoBalloon Ablation System Controller |
| Modular Type: | Does not apply |
| Grant Notes | FCC Rule Parts | Frequency Range (MHZ) | Output Watts | Frequency Tolerance | Emission Designator |
| 20 | 15C | 13.56 - 13.56 |
| USA federal law restricts this device to sale by or on the order of a physician. |
| 20: | All electrical and mechanical devices employed for spurious radiation suppression, including any modifications made during certification testing, must be incorporated in each unit marketed. |
| Mail To: |