The following data is part of a premarket notification filed by Vios Medical, Inc. with the FDA for Vios Monitoring System.
| Device ID | K150992 |
| 510k Number | K150992 |
| Device Name: | Vios Monitoring System |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | VIOS MEDICAL, INC. 7300 HUDSON BLVD N, STE 140 St. Paul, MN 55128 |
| Contact | Megan Graham |
| Correspondent | Megan Graham VIOS MEDICAL, INC. 7300 HUDSON BLVD N, STE 140 St. Paul, MN 55128 |
| Product Code | DRT |
| Subsequent Product Code | DRG |
| Subsequent Product Code | FLL |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-15 |
| Decision Date | 2015-12-16 |
| Summary: | summary |