WiCap
Oximeter
Athena GTX
The following data is part of a premarket notification filed by Athena Gtx with the FDA for Wicap.
Pre-market Notification Details
| Device ID | K160582 |
| 510k Number | K160582 |
| Device Name: | WiCap |
| Classification | Oximeter |
| Applicant | Athena GTX 5900 NW 86th Street, Suite 300 Johnston, IA 50131 |
| Contact | Sean Mahoney |
| Correspondent | Sean Mahoney Athena GTX 5900 NW 86th Street, Suite 300 Johnston, IA 50131 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-01 |
| Decision Date | 2016-09-02 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B3945200015010 | K160582 | 000 |
| B3945000016010 | K160582 | 000 |
Trademark Results [WiCap]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 WICAP 86517970 4807818 Live/Registered |
Athena GTX, Inc. 2015-01-29 |
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