Duteck Body Composition Analyzer

FDA 510(k) K060642 · Duteck Industrial Co., Ltd.

Substantially Equivalent

510(k) numberK060642

Submission

Device name
Duteck Body Composition Analyzer
Applicant
Duteck Industrial Co., Ltd.
Taipei, TW
Received
March 10, 2006
Decision date
June 7, 2006
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement 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 Duteck Body Composition Analyzer cleared by the FDA?

Duteck Body Composition Analyzer (K060642) received a 510(k) decision of Substantially Equivalent on June 7, 2006, 89 days after the submission was received.

What is the product code of K060642?

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