K201770 is an FDA 510(k) clearance for the Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensor. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by Masimo Corporation (Irvine, US). The FDA issued a Cleared decision on September 24, 2020, 87 days after receiving the submission on June 29, 2020.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K201770 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 29, 2020 |
| Decision Date | September 24, 2020 |
| Days to Decision | 87 days |
| Submission Type | Special |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | DQA — Oximeter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2700 |