K210305 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 Dongguan Lingxin Technologies Co., Ltd. (Dongguan, CN). The FDA issued a Cleared decision on December 22, 2021, 322 days after receiving the submission on February 3, 2021.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K210305 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 03, 2021 |
| Decision Date | December 22, 2021 |
| Days to Decision | 322 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 |