The following data is part of a premarket notification filed by Reynolds Medical Ltd. with the FDA for Tracker 2/tracker 3 Holter Recorder.
| Device ID | K943278 |
| 510k Number | K943278 |
| Device Name: | TRACKER 2/TRACKER 3 HOLTER RECORDER |
| Classification | Recorder, Magnetic Tape, Medical |
| Applicant | REYNOLDS MEDICAL LTD. 1-2 HARFORDE CT., FOXHOLES BUSINESS PARK Hertford, GB Sg13 7nw |
| Contact | Michael Maze |
| Correspondent | Michael Maze REYNOLDS MEDICAL LTD. 1-2 HARFORDE CT., FOXHOLES BUSINESS PARK Hertford, GB Sg13 7nw |
| Product Code | DSH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-07 |
| Decision Date | 1994-10-20 |