K231243
- 510(k) number
- K231243
- Device name
- Finger Clip Pulse Oximeter
- Applicant
- Guangdong Genial Technology Co., Ltd. CN
- Product code
- DQA — Oximeter
- Decision date
- 2023-10-31
- Date received
- 2023-05-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K231243
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.