K193242 is an FDA 510(k) clearance for the Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and Accessories, Masimo Radius-7 Pulse CO-Oximeter and Accessories. This device is classified as a Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (Class II - Special Controls, product code MWI).
Submitted by Masimo Corporation (Irvine, US). The FDA issued a Cleared decision on February 27, 2020, 94 days after receiving the submission on November 25, 2019.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2300.
| 510(k) Number | K193242 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 25, 2019 |
| Decision Date | February 27, 2020 |
| Days to Decision | 94 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | MWI — Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2300 |