Body Fat Analyzer and Scale

FDA 510(k) K140594 · Conmo Electronic Company Limited

Substantially Equivalent

510(k) numberK140594

Submission

Device name
Body Fat Analyzer and Scale
Applicant
Conmo Electronic Company Limited
Echo, AZ, US
Received
March 7, 2014
Decision date
May 30, 2014
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MNW – Analyzer, Body Composition
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2770
Specialty
Cardiovascular

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Questions and answers

When was Body Fat Analyzer and Scale cleared by the FDA?

Body Fat Analyzer and Scale (K140594) received a 510(k) decision of Substantially Equivalent on May 30, 2014, 84 days after the submission was received.

What is the product code of K140594?

The FDA product code is MNW – Analyzer, Body Composition, a Class II (moderate risk) device regulated under 21 CFR 870.2770.