510(k) K982975 ยท MWJ Electrocardiograph, Ambulatory (Without Analysis)
DIGITAL ECG HOLTER RECORDER, MODEL DR512
| Applicant | Datrix, Escondido CA, US |
| Decision | Substantially Equivalent, Nov 10, 1998 |
| Received | Aug 26, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982975
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.