The following data is part of a premarket notification filed by Applied Medical Research with the FDA for Minimap Model 810.
Device ID | K771981 |
510k Number | K771981 |
Device Name: | MINIMAP MODEL 810 |
Classification | Computer, Blood-pressure |
Applicant | APPLIED MEDICAL RESEARCH 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | DSK |
CFR Regulation Number | 870.1110 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-10-18 |
Decision Date | 1978-01-24 |