510(k) K120462 ยท MLO Electrocardiograph, Ambulatory, With Analysis Algorithm
AUDICOR CPAM WITH SDB (CARDIOPULMONARY AMBULATORY MONITOR WITH SLEEP DISORDERED BREATHING DETECTION)
| Applicant | Inovise Medical, Inc., Beaverton OR, US |
| Decision | Substantially Equivalent, Sep 20, 2012 |
| Received | Feb 15, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K120462
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.