The following data is part of a premarket notification filed by Reynolds Medical Ltd. with the FDA for Cardiodirect, Models 12m, 12i, 12s.
| Device ID | K024283 |
| 510k Number | K024283 |
| Device Name: | CARDIODIRECT, MODELS 12M, 12I, 12S |
| Classification | Electrocardiograph |
| 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 | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-23 |
| Decision Date | 2003-08-01 |
| Summary: | summary |