510(k) K001349 ยท MWJ Electrocardiograph, Ambulatory (Without Analysis)
CARDIOVISE ECG INTERPRETATIVE SOFTWARE
| Applicant | Inovise Medical, Inc., Newberg OR, US |
| Decision | Substantially Equivalent, Jul 27, 2000 |
| Received | Apr 28, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001349
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.