K231979
- 510(k) number
- K231979
- Device name
- Mecun SpO2 sensor
- Applicant
- Shenzhen Mecun Medical Supply Co., Ltd. CN
- Product code
- DQA — Oximeter
- Decision date
- 2024-08-16
- Date received
- 2023-07-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K231979.pdf
Official FDA record: K231979
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.