The following data is part of a premarket notification filed by Aequitron Medical, Inc. with the FDA for Modified Models 9500,9550,9200,8200,heart Rate Mon.
| Device ID | K902785 |
| 510k Number | K902785 |
| Device Name: | MODIFIED MODELS 9500,9550,9200,8200,HEART RATE MON |
| Classification | Monitor, Breathing Frequency |
| Applicant | AEQUITRON MEDICAL, INC. 14800 28TH AVE. NORTH Minneapolis, MN 55447 -4834 |
| Contact | Robert Samec |
| Correspondent | Robert Samec 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 | 1990-06-26 |
| Decision Date | 1990-07-13 |