K243049
- 510(k) number
- K243049
- Device name
- Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C)
- Applicant
- Hunan Accurate Bio-Medical Technology Co., Ltd. CN
- Product code
- DQA — Oximeter
- Decision date
- 2025-01-02
- Date received
- 2024-09-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K243049.pdf
Official FDA record: K243049
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.