K230277
- 510(k) number
- K230277
- Device name
- Pulse Oximeter(Model OHT60,OXH78)
- Applicant
- Cofoe Medical Technology Co., Ltd. CN
- Product code
- DQA — Oximeter
- Decision date
- 2024-01-04
- Date received
- 2023-02-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K230277.pdf
Official FDA record: K230277
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.