The following data is part of a premarket notification filed by Vios Medical, Inc. with the FDA for Vios Monitoring System™ Model 2050.
| Device ID | K172586 |
| 510k Number | K172586 |
| Device Name: | Vios Monitoring System™ Model 2050 |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | Vios Medical, Inc. 7300 Hudson Blvd N St. Paul, MN 55128 |
| Contact | Amit Patel |
| Correspondent | Megan Graham Vios Medical, Inc. 7300 Hudson Blvd N St. Paul, MN 55128 |
| Product Code | DRT |
| Subsequent Product Code | DPZ |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DRG |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-28 |
| Decision Date | 2018-06-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B595L2050G0 | K172586 | 000 |
| B595CS20500 | K172586 | 000 |
| B595L2050R0 | K172586 | 000 |
| B595BSM20500 | K172586 | 000 |