IMPEDIMED EXTRA CELLULAR FLUID ANALYSIS, MODEL L-DEX U400— 510(k) K080825

Name: FDA 510(k) clearance K080825
Creator: U.S. Food and Drug Administration
Published: 2008-10-03

Unknown

Impedimed Pty , Ltd.

FDA 510(k) clearance K080825 for IMPEDIMED EXTRA CELLULAR FLUID ANALYSIS, MODEL L-DEX U400, Unknown on 2008-10-03. Applicant: Impedimed Pty , Ltd.. Device class: 2.

Clearance details

Applicant: Impedimed Pty , Ltd.
Product code: Code OBH
Device class: Class 2
Regulation: 21 CFR 870.2770
Advisory panel: Cardiovascular
Date received: 2008-03-24
Decision date: 2008-10-03
Decision: Unknown
Clearance type: Traditional
Location: Pinkenba, Qld, AU

Download summary PDF View on FDA.gov ↗

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