K240092
- 510(k) number
- K240092
- Device name
- 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)
- Applicant
- Shenzhen Yimi Life Technology Co., Ltd. CN
- Product code
- DQA — Oximeter
- Decision date
- 2024-10-25
- Date received
- 2024-01-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 4.4 MB · U.S. public domain
Also available from FDA: K240092.pdf
Official FDA record: K240092
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.