The following data is part of a premarket notification filed by Aequitron Medical, Inc. with the FDA for Respiration/heart Rate Monitor Model 9500/9550.
| Device ID | K903020 |
| 510k Number | K903020 |
| Device Name: | RESPIRATION/HEART RATE MONITOR MODEL 9500/9550 |
| Classification | Monitor, Breathing Frequency |
| Applicant | AEQUITRON MEDICAL, INC. 14800 28TH AVE. NORTH Minneapolis, MN 55447 -4834 |
| Contact | Kenneth Herland |
| Correspondent | Kenneth Herland AEQUITRON MEDICAL, INC. 14800 28TH AVE. NORTH Minneapolis, MN 55447 -4834 |
| Product Code | BZQ |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-11 |
| Decision Date | 1991-04-10 |