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FDA 510(k)

MODIFICATION TO ZARGIS ACOUSTIC CARDIOSCAN (ZAC)

K-Number: K042128 · 2004-09-08

ApplicantZargis Medical Corp.
Decision Date2004-09-08
Product CodeDQD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO ZARGIS ACOUSTIC CARDIOSCAN (ZAC) 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 2004-09-08 under 510(k) number K042128. 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 MODIFICATION TO ZARGIS ACOUSTIC CARDIOSCAN (ZAC)?

MODIFICATION TO ZARGIS ACOUSTIC CARDIOSCAN (ZAC) is a medical device that received FDA 510(k) clearance on 2004-09-08. The listed applicant is Zargis Medical Corp.. The 510(k) number is K042128.

When did MODIFICATION TO ZARGIS ACOUSTIC CARDIOSCAN (ZAC) receive FDA 510(k) clearance?

MODIFICATION TO ZARGIS ACOUSTIC CARDIOSCAN (ZAC) received FDA 510(k) clearance on 2004-09-08, under 510(k) number K042128.

Who is the listed applicant for MODIFICATION TO ZARGIS ACOUSTIC CARDIOSCAN (ZAC)?

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 MODIFICATION TO ZARGIS ACOUSTIC CARDIOSCAN (ZAC)?

The FDA product code for MODIFICATION TO ZARGIS ACOUSTIC CARDIOSCAN (ZAC) is DQD.

Related Clinical Trials

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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 9.33K060197ZARGIS ACOUSTIC CARDIOSCAN (ZAC), MODEL ZAC 6.28K031517ZARGIS 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.

K261494Smart Wireless Stethoscope (STEMO310);Smart Wireless Stethoscope (STEMO710);Smart Wireless Stethoscope (STEMO720);Smart Wireless Stethoscope (STEMO730)Shanghai Hulu Devices Co., Ltd.K261694CORE 300 Digital StethoscopeEko Health, Inc.K252915AiSteth®Ai Health Highway India Pvt., Ltd.K252089Tyto Stethoscope (G3)Tyto Care , Ltd.K252076Kneevoice Cartilage Evaluation System (750-3600-001)Kneevoice, Inc.K252284eMurmur Heart AICsd Labs

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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