The following data is part of a premarket notification filed by Circadian, Inc. with the FDA for Circa Med Single-channel-ambulatory Cardiac Monito.
| Device ID | K851517 |
| 510k Number | K851517 |
| Device Name: | CIRCA MED SINGLE-CHANNEL-AMBULATORY CARDIAC MONITO |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | CIRCADIAN, INC. 3942 NORTH FIRST ST. San Jose, CA 95134 -1501 |
| Contact | Robert J Sudol |
| Correspondent | Robert J Sudol 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 | 1985-04-15 |
| Decision Date | 1985-10-02 |