Cleared Traditional

BODY FAT ANALYZER AND SCALE

K140594 · Conmo Electronic Company Limited · Gastroenterology & Urology
May 2014
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K140594 is an FDA 510(k) clearance for the BODY FAT ANALYZER AND SCALE, a Analyzer, Body Composition (Class II — Special Controls, product code MNW), submitted by Conmo Electronic Company Limited (Echo, US). The FDA issued a Cleared decision on May 30, 2014, 84 days after receiving the submission on March 7, 2014. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 870.2770.

Submission Details

510(k) Number K140594 FDA.gov
FDA Decision Cleared SESE
Date Received March 07, 2014
Decision Date May 30, 2014
Days to Decision 84 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code MNW — Analyzer, Body Composition
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2770