510(k) K141483

BIOSPACE BODY COMPOSITION ANALYZER by Biospace Corporation Limited — Product Code MNW

K141483 is an FDA 510(k) premarket notification submitted by Biospace Corporation Limited for the device "BIOSPACE BODY COMPOSITION ANALYZER". The FDA issued a decision of Substantially Equivalent on September 23, 2014. 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
September 23, 2014
Date Received
June 5, 2014
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