Clockmini, Model DF301; Clocknavi, Model DF311

FDA 510(k) K023942 · Yamato Corp.

Substantially Equivalent

510(k) numberK023942

Submission

Device name
Clockmini, Model DF301; Clocknavi, Model DF311
Applicant
Yamato Corp.
Denver, CO, US
Received
November 26, 2002
Decision date
February 24, 2003
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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K130952Precision One Lifecare; Detecto; DetectoMNW · Traditional Precision One Lifecare, Ltd.09/26/2013SE
K131394Transtek Glass Body Fat AnalyzerMNW · Special Guangdong Transtek Medical Electronics Co., Ltd.09/18/2013SE
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Questions and answers

When was Clockmini, Model DF301; Clocknavi, Model DF311 cleared by the FDA?

Clockmini, Model DF301; Clocknavi, Model DF311 (K023942) received a 510(k) decision of Substantially Equivalent on February 24, 2003, 90 days after the submission was received.

What is the product code of K023942?

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