The following data is part of a premarket notification filed by Creative Medical, Inc. with the FDA for Cardiac Communicator 2000.
| Device ID | K852654 |
| 510k Number | K852654 |
| Device Name: | CARDIAC COMMUNICATOR 2000 |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | CREATIVE MEDICAL, INC. 725 N. BLACK HORSE PIKE Runnemede, NJ 08078 |
| Contact | Alan P Schwartz |
| Correspondent | Alan P Schwartz CREATIVE MEDICAL, INC. 725 N. BLACK HORSE PIKE Runnemede, NJ 08078 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-24 |
| Decision Date | 1985-12-04 |