The following data is part of a premarket notification filed by Vios Medical, Inc. with the FDA for Vios Central Station Monitor Software, Vios Central Server Software.
| Device ID | K173107 |
| 510k Number | K173107 |
| Device Name: | Vios Central Station Monitor Software, Vios Central Server Software |
| Classification | Display, Cathode-ray Tube, Medical |
| 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 | DXJ |
| CFR Regulation Number | 870.2450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-29 |
| Decision Date | 2018-07-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B595VMM2050 | K173107 | 000 |
| B595VCS2050 | K173107 | 000 |
| B595CSM20500 | K173107 | 000 |