The following data is part of a premarket notification filed by Reynolds Medical Ltd. with the FDA for Cardionavigator Information Management System.
| Device ID | K011345 |
| 510k Number | K011345 |
| Device Name: | CARDIONAVIGATOR INFORMATION MANAGEMENT SYSTEM |
| 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 | 2001-05-02 |
| Decision Date | 2001-07-20 |