The following data is part of a premarket notification filed by Vita-stat Medical Services, Inc. with the FDA for Vita-stat Model 900-s.
Device ID | K792194 |
510k Number | K792194 |
Device Name: | VITA-STAT MODEL 900-S |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | VITA-STAT MEDICAL SERVICES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | DXN |
CFR Regulation Number | 870.1130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-11-01 |
Decision Date | 1979-11-20 |