The following data is part of a premarket notification filed by Reynolds Medical Ltd. with the FDA for Cardiocall Cardiac Event Recorder.
| Device ID | K972649 |
| 510k Number | K972649 |
| Device Name: | CARDIOCALL CARDIAC EVENT RECORDER |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | REYNOLDS MEDICAL LTD. 377 RT. 17 S. Hasbrouck Heights, NJ 07604 |
| Contact | George Myers |
| Correspondent | George Myers REYNOLDS MEDICAL LTD. 377 RT. 17 S. Hasbrouck Heights, NJ 07604 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-15 |
| Decision Date | 1997-12-04 |
| Summary: | summary |