K213431 is an FDA 510(k) clearance for the Handheld Pulse Oximeter. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by Shenzhen Witleaf Medical Electronics Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on February 26, 2023, 493 days after receiving the submission on October 21, 2021.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K213431 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 21, 2021 |
| Decision Date | February 26, 2023 |
| Days to Decision | 493 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 |