510(k) K180782
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 20, 2018
- Date Received
- March 26, 2018
- 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