510(k) K113725
K113725 is an FDA 510(k) premarket notification submitted by O.N. Diagnostics for the device "VIRTUOST". The FDA issued a decision of Substantially Equivalent on September 13, 2012. The device falls under product code KGI (Densitometer, Bone), a Class II device regulated under 21 CFR 892.1170. O.N. Diagnostics has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 13, 2012
- Date Received
- December 19, 2011
- 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