510(k) K063690 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
COLIN PRESS MATE, MODEL BP S510
| Applicant | Omron Healthcare, Inc., Bonita Springs FL, US |
| Decision | Substantially Equivalent, May 9, 2007 |
| Received | Dec 12, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K063690
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.