The following data is part of a premarket notification filed by Datrix with the FDA for Gikter Ecg Cassette Tape Recorder Model Xr 300.
| Device ID | K921068 |
| 510k Number | K921068 |
| Device Name: | GIKTER ECG CASSETTE TAPE RECORDER MODEL XR 300 |
| Classification | Recorder, Magnetic Tape, Medical |
| Applicant | DATRIX 1312 GARY LN. Escondido, CA 92026 |
| Contact | Jon Barron |
| Correspondent | Jon Barron DATRIX 1312 GARY LN. Escondido, CA 92026 |
| Product Code | DSH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-06 |
| Decision Date | 1992-03-30 |