Stayhealthy Body Composition Analyzer, Models BC1 and BC2

FDA 510(k) K052522 · Stayhealthy, Inc.

Substantially Equivalent

510(k) numberK052522

Submission

Device name
Stayhealthy Body Composition Analyzer, Models BC1 and BC2
Applicant
Stayhealthy, Inc.
Monrovia, CA, US
Received
September 14, 2005
Decision date
December 13, 2005
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 Stayhealthy Body Composition Analyzer, Models BC1 and BC2 cleared by the FDA?

Stayhealthy Body Composition Analyzer, Models BC1 and BC2 (K052522) received a 510(k) decision of Substantially Equivalent on December 13, 2005, 90 days after the submission was received.

What is the product code of K052522?

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