510(k) K092786

INBODY, MODELS: 270, R20, R20B by Biospace Corporation Limited — Product Code MNW

K092786 is an FDA 510(k) premarket notification submitted by Biospace Corporation Limited for the device "INBODY, MODELS: 270, R20, R20B". The FDA issued a decision of Substantially Equivalent on March 10, 2010. 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
March 10, 2010
Date Received
September 10, 2009
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