The following data is part of a premarket notification filed by Athena Gtx with the FDA for Wvsm (wirless Vital Signs Monitor).
| Device ID | K130957 |
| 510k Number | K130957 |
| Device Name: | WVSM (WIRLESS VITAL SIGNS MONITOR) |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | ATHENA GTX 3620 SW61ST STREET SUITE 395 Des Moines, IA 50321 |
| Contact | Sean Mahoney |
| Correspondent | Sean Mahoney ATHENA GTX 3620 SW61ST STREET SUITE 395 Des Moines, IA 50321 |
| Product Code | MWI |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DRG |
| Subsequent Product Code | DXN |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-05 |
| Decision Date | 2013-04-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B3943950006000 | K130957 | 000 |