The following data is part of a premarket notification filed by Circadian, Inc. with the FDA for Circadian Stress Test System.
| Device ID | K860973 |
| 510k Number | K860973 |
| Device Name: | CIRCADIAN STRESS TEST SYSTEM |
| Classification | Electrocardiograph |
| 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 | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-14 |
| Decision Date | 1986-08-25 |