IMPEDIMED - BODY COMPOSITION ANALYSIS— 510(k) K050395

Name: FDA 510(k) clearance K050395
Creator: U.S. Food and Drug Administration
Published: 2005-07-13

Substantially Equivalent

Impedimed Pty , Ltd.

FDA 510(k) clearance K050395 for IMPEDIMED - BODY COMPOSITION ANALYSIS, Substantially Equivalent on 2005-07-13. Applicant: Impedimed Pty , Ltd.. Device class: 2.

Clearance details

Applicant: Impedimed Pty , Ltd.
Product code: Code MNW
Device class: Class 2
Regulation: 21 CFR 870.2770
Advisory panel: Cardiovascular
Date received: 2005-02-16
Decision date: 2005-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brisbane, Queensland, AU

Download summary PDF View on FDA.gov ↗

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