510(k) K130952

PRECISION ONE LIFECARE; DETECTO; DETECTO by Precision One Lifecare, Ltd. — Product Code MNW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 2013
Date Received
April 5, 2013
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