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.. Device class: 2.
Clearance details
- Applicant
- Shanghai Handy Medical Equipment Co., Ltd.
- Product code
- Code MUH
- Device class
- Class 2
- Regulation
- 21 CFR 872.1800
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Baoshan District, CN
Recent devices under product code MUH
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