510(k) K051212 ยท DQA Oximeter
MODIFICATION TO LNCS OXIMETRY SENSORS
| Applicant | Masimo Corporation, Irvine CA, US |
| Decision | Substantially Equivalent, Jul 12, 2005 |
| Received | May 11, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K051212
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 21, 2023 | Masimo Corporation Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 1895 Open, Classified |
DQA | None listed |
| Jun 21, 2023 | Masimo Corporation Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 2503 Open, Classified |
DQA | None listed |
| Apr 4, 2016 | Merge Healthcare, Inc. SpO2 connecting cable for Masimo LNCS sensor (Merge Part Number: HW-HEMO-00014),
Product Usage:
Merge Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing Terminated |
DQK | None listed |
| Apr 4, 2016 | Merge Healthcare, Inc. Masimo SPO2 Sensor, ear clip-adult (Merge Part Number: HW-HEMO-00047),
Product Usage:
Merge Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing a cardiac Terminated |
DQA | None listed |
| Apr 4, 2016 | Merge Healthcare, Inc. MasimoSET LNOP DCIP pediatric/slender digit SpO2 reusable sensor, finger clip pediatric (Merge Part Number: HW-HEMO-00076),
Product Usage:
Merge Hemodynamics monitors, measures, and records physio Terminated |
DQA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.