510(k) K971670 ยท DSH Recorder, Magnetic Tape, Medical
3 CHANNEL DIGITAL AMBULATORY ECG RECORDER
| Applicant | Galix Biomedical Instrumentation, Inc., Miami Beach FL, US |
| Decision | Substantially Equivalent, Jan 29, 1998 |
| Received | May 6, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971670
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.