K203854 is an FDA 510(k) clearance for the Pulse Oximeter. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by Shenzhen Hexin Zondan Medical Equipment Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on April 23, 2021, 113 days after receiving the submission on December 31, 2020.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K203854 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 31, 2020 |
| Decision Date | April 23, 2021 |
| Days to Decision | 113 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 |