K230277 is an FDA 510(k) clearance for the Pulse Oximeter(Model OHT60,OXH78). This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by Cofoe Medical Technology Co., Ltd. (Changsha, CN). The FDA issued a Cleared decision on January 4, 2024, 337 days after receiving the submission on February 1, 2023.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K230277 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 01, 2023 |
| Decision Date | January 04, 2024 |
| Days to Decision | 337 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 |