510(k) K211561 ยท MUD Oximeter, Tissue Saturation
INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor)
| Applicant | Covidien, LLC, Boulder CO, US |
| Decision | Substantially Equivalent, Dec 5, 2021 |
| Received | May 20, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211561
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 30, 2024 | Covidien Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100, REF: PMAC71RIC Open, Classified |
MUD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.