K183697 is an FDA 510(k) clearance for the Masimo Rad-97 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 May 15, 2019, 135 days after receiving the submission on December 31, 2018.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2300.
| 510(k) Number | K183697 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 31, 2018 |
| Decision Date | May 15, 2019 |
| Days to Decision | 135 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 |