ZARGIS ACOUSTIC CARDIOSCAN (ZAC), MODEL ZAC 6.28— 510(k) K060197

Name: FDA 510(k) clearance K060197
Creator: U.S. Food and Drug Administration
Published: 2006-03-29

Substantially Equivalent

Zargis Medical Corp.

FDA 510(k) clearance K060197 for ZARGIS ACOUSTIC CARDIOSCAN (ZAC), MODEL ZAC 6.28, Substantially Equivalent on 2006-03-29. Applicant: Zargis Medical Corp.. Device class: 2.

Clearance details

Applicant: Zargis Medical Corp.
Product code: Code DQD
Device class: Class 2
Regulation: 21 CFR 870.1875
Advisory panel: Cardiovascular
Date received: 2006-01-26
Decision date: 2006-03-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Princeton, NJ, US

Download summary PDF View on FDA.gov ↗

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