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FDA 510(k)

ZARGIS ACOUSTIC CARDIOSCAN (ZAC), MODEL ZAC 6.28

K-Number: K060197 · 2006-03-29

ApplicantZargis Medical Corp.
Decision Date2006-03-29
Product CodeDQD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ZARGIS ACOUSTIC CARDIOSCAN (ZAC), MODEL ZAC 6.28 is the device name listed in this FDA 510(k) record. The listed applicant is Zargis Medical Corp.. It received FDA 510(k) clearance on 2006-03-29 under 510(k) number K060197. The device is classified under product code DQD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZARGIS ACOUSTIC CARDIOSCAN (ZAC), MODEL ZAC 6.28?

ZARGIS ACOUSTIC CARDIOSCAN (ZAC), MODEL ZAC 6.28 is a medical device that received FDA 510(k) clearance on 2006-03-29. The listed applicant is Zargis Medical Corp.. The 510(k) number is K060197.

When did ZARGIS ACOUSTIC CARDIOSCAN (ZAC), MODEL ZAC 6.28 receive FDA 510(k) clearance?

ZARGIS ACOUSTIC CARDIOSCAN (ZAC), MODEL ZAC 6.28 received FDA 510(k) clearance on 2006-03-29, under 510(k) number K060197.

Who is the listed applicant for ZARGIS ACOUSTIC CARDIOSCAN (ZAC), MODEL ZAC 6.28?

The FDA 510(k) record lists Zargis Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ZARGIS ACOUSTIC CARDIOSCAN (ZAC), MODEL ZAC 6.28?

The FDA product code for ZARGIS ACOUSTIC CARDIOSCAN (ZAC), MODEL ZAC 6.28 is DQD.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Zargis Medical Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K090493SIGNALK083309ZARGIS ACOUSTIC CARDIOSCAN, VERSION 9.33K042128MODIFICATION TO ZARGIS ACOUSTIC CARDIOSCAN (ZAC)K031517ZARGIS ACOUSTIC CARDIOSCAN

Related Devices (Code: DQD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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