K212665 is an FDA 510(k) clearance for the Pulse Oximeter (Model Number-SO611), Pulse Oximeter (Model Number- S0711), Pulse Oximeter (S0811), Pulse Oximeter (S0911). This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by Huizhou Xiaoou Technology Co., Ltd. (Huizhou, CN). The FDA issued a Cleared decision on June 22, 2022, 303 days after receiving the submission on August 23, 2021.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K212665 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 23, 2021 |
| Decision Date | June 22, 2022 |
| Days to Decision | 303 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | DQA - Oximeter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2700 |