510(k) K062603

BIOSPACE BODY COMPOSITION ANALYZERS, MODEL INBODY 230 by Biospace Corporation Limited — Product Code MNW

K062603 is an FDA 510(k) premarket notification submitted by Biospace Corporation Limited for the device "BIOSPACE BODY COMPOSITION ANALYZERS, MODEL INBODY 230". The FDA issued a decision of Substantially Equivalent on February 15, 2007. 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
February 15, 2007
Date Received
September 1, 2006
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