510(k) K220822
K220822 is an FDA 510(k) premarket notification submitted by 3D-Shaper Medical S.L for the device "3D-SHAPER". The FDA issued a decision of Substantially Equivalent on December 9, 2022. The device falls under product code KGI (Densitometer, Bone), a Class II device regulated under 21 CFR 892.1170. 3D-Shaper Medical S.L has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 9, 2022
- Date Received
- March 21, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Densitometer, Bone
- Device Class
- Class II
- Regulation Number
- 892.1170
- Review Panel
- RA
- Submission Type