K212385 is an FDA 510(k) clearance for the YUWELL Finger Pulse Oximeter. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. (Danyang, CN). The FDA issued a Cleared decision on August 16, 2022, 379 days after receiving the submission on August 2, 2021.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K212385 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 02, 2021 |
| Decision Date | August 16, 2022 |
| Days to Decision | 379 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 |