K240092 is an FDA 510(k) clearance for the Pulse Oximeter (YM101, YM102, YM103, YM104, YM201, YM301, YM202, YM302, YM111, YM112, YM113, YM114, YM211, YM212, YM314, YM601, YM602, YM401, YM402, YM403, YM501, YM502, YM503 and YM504). This device is classified as a Oximeter (Class II - Special Controls, product code DQA).
Submitted by Shenzhen Yimi Life-Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on October 25, 2024, 287 days after receiving the submission on January 12, 2024.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K240092 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 12, 2024 |
| Decision Date | October 25, 2024 |
| Days to Decision | 287 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 |