The following data is part of a premarket notification filed by Athena Gtx with the FDA for Wvsm (wireless Vital Signs Monitor) Rwc + Minicap.
| Device ID | K191989 |
| 510k Number | K191989 |
| Device Name: | WVSM (Wireless Vital Signs Monitor) RWC + MiniCap |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| 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 | MWI |
| Subsequent Product Code | CCK |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DRG |
| Subsequent Product Code | DXN |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-25 |
| Decision Date | 2020-01-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B3945700047020 | K191989 | 000 |
| B3945700047010 | K191989 | 000 |
| B394530023020 | K191989 | 000 |
| B3945300023010 | K191989 | 000 |
| B3945000034040 | K191989 | 000 |
| B3945000034030 | K191989 | 000 |
| B3945000034020 | K191989 | 000 |
| B3945000034010 | K191989 | 000 |
| B3944670019010 | K191989 | 000 |