The following data is part of a premarket notification filed by Reynolds Medical Ltd. with the FDA for Lifecard Cf Compact Recorder.
| Device ID | K001025 |
| 510k Number | K001025 |
| Device Name: | LIFECARD CF COMPACT RECORDER |
| Classification | Recorder, Magnetic Tape, Medical |
| 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 | DSH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-30 |
| Decision Date | 2000-04-19 |