HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2)— 510(k) K221008
Substantially EquivalentShanghai Handy Medical Equipment Co., Ltd.
FDA 510(k) clearance K221008 for HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2), Substantially Equivalent on 2022-06-22. Applicant: Shanghai Handy Medical Equipment Co., Ltd..
Clearance details
- Applicant
- Shanghai Handy Medical Equipment Co., Ltd.
- Product code
- Code MUH
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Baoshan District, CN
Data sourced from openFDA. This site is unofficial and independent of the FDA.