The following data is part of a premarket notification filed by Circadian, Inc. with the FDA for Circamed Full Disclosure System.
| Device ID | K871251 |
| 510k Number | K871251 |
| Device Name: | CIRCAMED FULL DISCLOSURE SYSTEM |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | CIRCADIAN, INC. 3942 NORTH FIRST ST. San Jose, CA 95134 -1501 |
| Contact | Matt S Magoun |
| Correspondent | Matt S Magoun CIRCADIAN, INC. 3942 NORTH FIRST ST. San Jose, CA 95134 -1501 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-30 |
| Decision Date | 1987-05-22 |