Body Fat Scale Model SF-371

FDA 510(k) K122976 · Shenzhen Belter Health Measurement and Analysis TE

Substantially Equivalent

510(k) numberK122976

Submission

Device name
Body Fat Scale Model SF-371
Applicant
Shenzhen Belter Health Measurement and Analysis TE
Echo, OR, US
Received
September 26, 2012
Decision date
January 4, 2013
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 Scale Model SF-371 cleared by the FDA?

Body Fat Scale Model SF-371 (K122976) received a 510(k) decision of Substantially Equivalent on January 4, 2013, 100 days after the submission was received.

What is the product code of K122976?

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