Bodystat

FDA 510(k) K002835 · Bodystat , Ltd.

Substantially Equivalent

510(k) numberK002835

Submission

Device name
Bodystat
Applicant
Bodystat , Ltd.
British Isles, GB
Received
September 12, 2000
Decision date
July 3, 2001
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 Bodystat cleared by the FDA?

Bodystat (K002835) received a 510(k) decision of Substantially Equivalent on July 3, 2001, 294 days after the submission was received.

What is the product code of K002835?

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