510(k) K221008
K221008 is an FDA 510(k) premarket notification submitted by Shanghai Handy Medical Equipment Co., Ltd. for the device "HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2)". The FDA issued a decision of Substantially Equivalent on Jun 22, 2022. The device falls under product code MUH (System, X-Ray, Extraoral Source, Digital), a Class II device regulated under 21 CFR 872.1800.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 22, 2022
- Date Received
- Apr 5, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Extraoral Source, Digital
- Device Class
- Class II
- Regulation Number
- 872.1800
- Review Panel
- RA
- Submission Type
- 510(k)