The following data is part of a premarket notification filed by Aequitron Medical, Inc. with the FDA for Respiration/8100-heart Rate Recorder.
| Device ID | K833348 |
| 510k Number | K833348 |
| Device Name: | RESPIRATION/8100-HEART RATE RECORDER |
| Classification | Recorder, Magnetic Tape, Medical |
| Applicant | AEQUITRON MEDICAL, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DSH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-09-27 |
| Decision Date | 1984-04-17 |