The following data is part of a premarket notification filed by Vocare, Inc. with the FDA for Vitals360 Multi-vitals Mobile Monitor.
| Device ID | K210086 |
| 510k Number | K210086 |
| Device Name: | Vitals360 Multi-Vitals Mobile Monitor |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | VoCare, Inc. 4950 Turkey Foot Road Zionsville, IN 46077 |
| Contact | Steve Peabody |
| Correspondent | Deon Vigilance VoCare, Inc. 4950 Turkey Foot Road Zionsville, IN 46077 |
| Product Code | MWI |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DSH |
| Subsequent Product Code | DXN |
| Subsequent Product Code | FLL |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-13 |
| Decision Date | 2021-05-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10860007323406 | K210086 | 000 |