Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SIGNAL

K-Number: K090493 · 2009-08-07

ApplicantZargis Medical Corp.
Decision Date2009-08-07
Product CodeDQD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SIGNAL 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 2009-08-07 under 510(k) number K090493. 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 SIGNAL?

SIGNAL is a medical device that received FDA 510(k) clearance on 2009-08-07. The listed applicant is Zargis Medical Corp.. The 510(k) number is K090493.

When did SIGNAL receive FDA 510(k) clearance?

SIGNAL received FDA 510(k) clearance on 2009-08-07, under 510(k) number K090493.

Who is the listed applicant for SIGNAL?

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 SIGNAL?

The FDA product code for SIGNAL 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Related PubMed Literature

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.

PMID: 32128936Medical device active surveillance of spontaneous reports: A literature review of signal detection methods.Pharmacoepidemiology and drug safety ()

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.

K083309ZARGIS ACOUSTIC CARDIOSCAN, VERSION 9.33K060197ZARGIS ACOUSTIC CARDIOSCAN (ZAC), MODEL ZAC 6.28K042128MODIFICATION 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.

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

View on FDA Database →

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

↑