The following data is part of a premarket notification filed by Aequitron Medical, Inc. with the FDA for Model Ami Infant Central Aphea/heart Rate Monitor.
| Device ID | K961972 |
| 510k Number | K961972 |
| Device Name: | MODEL AMI INFANT CENTRAL APHEA/HEART RATE MONITOR |
| Classification | Monitor, Breathing Frequency |
| Applicant | AEQUITRON MEDICAL, INC. 14800 28TH AVE. NORTH Minneapolis, MN 55447 |
| Contact | Robert C Samec |
| Correspondent | Robert C Samec AEQUITRON MEDICAL, INC. 14800 28TH AVE. NORTH Minneapolis, MN 55447 |
| Product Code | BZQ |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Se Subject To Tracking Reg (ST) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-20 |
| Decision Date | 1997-04-18 |
| Summary: | summary |