510(k) K071570
K071570 is an FDA 510(k) premarket notification submitted by Ge Medical Systems Lunar for the device "GE LUNAR BODY COMPOSITION SOFTWARE". The FDA issued a decision of Substantially Equivalent on June 27, 2007. The device falls under product code KGI (Densitometer, Bone), a Class II device regulated under 21 CFR 892.1170. Ge Medical Systems Lunar has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 27, 2007
- Date Received
- June 8, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Densitometer, Bone
- Device Class
- Class II
- Regulation Number
- 892.1170
- Review Panel
- RA
- Submission Type