510(k) K052646
K052646 is an FDA 510(k) premarket notification submitted by Biospace Corporation Limited for the device "BIOSPACE BODY COMPOSITION ANALYZERS, MODELS INBODY 520, 720 AND S20". The FDA issued a decision of Substantially Equivalent on December 16, 2005. 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
- December 16, 2005
- Date Received
- September 26, 2005
- Clearance Type
- Special
- 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