The following data is part of a premarket notification filed by Cardiac Care Units, Inc. with the FDA for Compas 1.
| Device ID | K853209 |
| 510k Number | K853209 |
| Device Name: | COMPAS 1 |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | CARDIAC CARE UNITS, INC. 6911 HAYVENHURST AVE. Van Nuys, CA 91406 |
| Contact | Thomas M Curran |
| Correspondent | Thomas M Curran CARDIAC CARE UNITS, INC. 6911 HAYVENHURST AVE. Van Nuys, CA 91406 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-31 |
| Decision Date | 1985-11-05 |