510(k) K113616
K113616 is an FDA 510(k) premarket notification submitted by Lone Oak Medical Technologies, LLC for the device "ACCUDXA2". The FDA issued a decision of Substantially Equivalent on April 27, 2012. The device falls under product code KGI (Densitometer, Bone), a Class II device regulated under 21 CFR 892.1170.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 27, 2012
- Date Received
- December 7, 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