Bia / Vitality Analyzer

FDA 510(k) K130856 · Ipgdx, LLC

Substantially Equivalent

510(k) numberK130856

Submission

Device name
Bia / Vitality Analyzer
Applicant
Ipgdx, LLC
Littleton, CO, US
Received
March 28, 2013
Decision date
November 25, 2013
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 Bia / Vitality Analyzer cleared by the FDA?

Bia / Vitality Analyzer (K130856) received a 510(k) decision of Substantially Equivalent on November 25, 2013, 242 days after the submission was received.

What is the product code of K130856?

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