MODIFICATION TO ZARGIS ACOUSTIC CARDIOSCAN (ZAC)— 510(k) K042128

Name: FDA 510(k) clearance K042128
Creator: U.S. Food and Drug Administration
Published: 2004-09-08

Substantially Equivalent

Zargis Medical Corp.

FDA 510(k) clearance K042128 for MODIFICATION TO ZARGIS ACOUSTIC CARDIOSCAN (ZAC), Substantially Equivalent on 2004-09-08. 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: 2004-08-06
Decision date: 2004-09-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Princeton, NJ, US

Download summary PDF View on FDA.gov ↗

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