The following data is part of a premarket notification filed by Applied Medical Research with the FDA for Recorder, Dinmap, Model 950.
Device ID | K771932 |
510k Number | K771932 |
Device Name: | RECORDER, DINMAP, MODEL 950 |
Classification | Recorder, Magnetic Tape, Medical |
Applicant | APPLIED MEDICAL RESEARCH 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DSH |
CFR Regulation Number | 870.2800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-10-14 |
Decision Date | 1977-11-07 |