The following data is part of a premarket notification filed by Applied Medical Research with the FDA for Dinamap Model 825a.
Device ID | K771772 |
510k Number | K771772 |
Device Name: | DINAMAP MODEL 825A |
Classification | Computer, Blood-pressure |
Applicant | APPLIED MEDICAL RESEARCH 803 N. Front St. Suite 3 McHenry, IL 60050 |
Product Code | DSK |
CFR Regulation Number | 870.1110 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-09-19 |
Decision Date | 1977-10-04 |