K211561 is an FDA 510(k) clearance for the INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor). This device is classified as a Oximeter, Tissue Saturation (Class II - Special Controls, product code MUD).
Submitted by Covidien, LLC (Boulder, US). The FDA issued a Cleared decision on December 5, 2021, 199 days after receiving the submission on May 20, 2021.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K211561 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 20, 2021 |
| Decision Date | December 05, 2021 |
| Days to Decision | 199 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | MUD — Oximeter, Tissue Saturation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2700 |