The following data is part of a premarket notification filed by Reynolds Medical Ltd. with the FDA for Tracker-2 Channel Ecg Tape Recorder.
| Device ID | K821516 |
| 510k Number | K821516 |
| Device Name: | TRACKER-2 CHANNEL ECG TAPE RECORDER |
| Classification | Recorder, Magnetic Tape, Medical |
| Applicant | REYNOLDS MEDICAL LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DSH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-05-21 |
| Decision Date | 1982-05-28 |