510(k) K123228

INBODY 770, INBODY 570, INBODY S10, INBODY H20/INBODY H20(B) by Biospace Corporation Limited — Product Code MNW

K123228 is an FDA 510(k) premarket notification submitted by Biospace Corporation Limited for the device "INBODY 770, INBODY 570, INBODY S10, INBODY H20/INBODY H20(B)". The FDA issued a decision of Substantially Equivalent on March 8, 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
March 8, 2013
Date Received
October 15, 2012
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