The following data is part of a premarket notification filed by Applied Cardiac Systems with the FDA for The Holter Reporter (tm).
| Device ID | K860249 |
| 510k Number | K860249 |
| Device Name: | THE HOLTER REPORTER (TM) |
| Classification | Electrocardiograph |
| Applicant | APPLIED CARDIAC SYSTEMS 22912 EL PACIFICO DR. Laguna Hills, CA 92653 |
| Contact | Dan Marcus |
| Correspondent | Dan Marcus APPLIED CARDIAC SYSTEMS 22912 EL PACIFICO DR. Laguna Hills, CA 92653 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-24 |
| Decision Date | 1986-03-11 |