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 |