510(k) K052646

BIOSPACE BODY COMPOSITION ANALYZERS, MODELS INBODY 520, 720 AND S20 by Biospace Corporation Limited — Product Code MNW

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