510(k) K071645 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
MODEL HBP T-105 SERIES, MODEL T-105 AND T-105S
| Applicant | Omron Healthcare, Inc., Bonita Springs FL, US |
| Decision | Substantially Equivalent, Jul 2, 2007 |
| Received | Jun 15, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K071645
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.