The following data is part of a premarket notification filed by Aegis Medical Systems, Inc. with the FDA for Aegis Ambulatory Monitoring System.
| Device ID | K843503 |
| 510k Number | K843503 |
| Device Name: | AEGIS AMBULATORY MONITORING SYSTEM |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | AEGIS MEDICAL SYSTEMS, INC. 3000 LINCLON DRIVE E Marlton , NJ 08053 - |
| Contact | John R Moreno |
| Correspondent | John R Moreno AEGIS MEDICAL SYSTEMS, INC. 3000 LINCLON DRIVE E Marlton , NJ 08053 - |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-06 |
| Decision Date | 1984-10-26 |