The following data is part of a premarket notification filed by Circadian, Inc. with the FDA for Circamed Holter Version 4.
| Device ID | K894956 |
| 510k Number | K894956 |
| Device Name: | CIRCAMED HOLTER VERSION 4 |
| Classification | Electrocardiograph |
| Applicant | CIRCADIAN, INC. 3942 NORTH FIRST ST. San Jose, CA 95134 -1501 |
| Contact | Robert Leiser |
| Correspondent | Robert Leiser 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 | 1989-08-04 |
| Decision Date | 1990-02-05 |