510(k) K130777
K130777 is an FDA 510(k) premarket notification submitted by Biospace Corporation Limited for the device "INBODY". The FDA issued a decision of Substantially Equivalent on November 25, 2013. The device falls under product code MNW (Analyzer, Body Composition), a Class II device regulated under 21 CFR 870.2770. Biospace Corporation Limited has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 25, 2013
- Date Received
- March 21, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Analyzer, Body Composition
- Device Class
- Class II
- Regulation Number
- 870.2770
- Review Panel
- GU
- Submission Type