510(k) K090662 ยท DQA Oximeter
MASIMO SET REUSABLE SOFT OXIMETRY SENSORS - ADULT / PEDICATRICS, MODEL DBI/ DBIP
| Applicant | Masimo Corporation, Irvine CA, US |
| Decision | Substantially Equivalent, Aug 10, 2009 |
| Received | Mar 12, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090662
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 4, 2016 | Merge Healthcare, Inc. MasimoSET LNOP DCI adult SpO2 reusable sensor, adult finger clip (Merge Part Number: HW-HEMO-00075),
Product Usage:
Merge Hemodynamics monitors, measures, and records physiologic data from a human Terminated |
DQA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.