The following data is part of a premarket notification filed by Aequitron Medical, Inc. with the FDA for Model 9216 Respiration/heart Rate Monitor.
| Device ID | K881266 |
| 510k Number | K881266 |
| Device Name: | MODEL 9216 RESPIRATION/HEART RATE MONITOR |
| Classification | Monitor, Breathing Frequency |
| Applicant | AEQUITRON MEDICAL, INC. 14800 28TH AVE. NORTH Minneapolis, MN 55447 -4834 |
| Contact | Kenneth B Herland |
| Correspondent | Kenneth B 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 | 1988-03-24 |
| Decision Date | 1988-06-10 |