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FDA 510(k)

ELECTRONIC STETHOSCOPE

K-Number: K121144 · 2012-09-26

ApplicantSharp Corporation
Decision Date2012-09-26
Product CodeDQD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ELECTRONIC STETHOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Sharp Corporation. It received FDA 510(k) clearance on 2012-09-26 under 510(k) number K121144. 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 ELECTRONIC STETHOSCOPE?

ELECTRONIC STETHOSCOPE is a medical device that received FDA 510(k) clearance on 2012-09-26. The listed applicant is Sharp Corporation. The 510(k) number is K121144.

When did ELECTRONIC STETHOSCOPE receive FDA 510(k) clearance?

ELECTRONIC STETHOSCOPE received FDA 510(k) clearance on 2012-09-26, under 510(k) number K121144.

Who is the listed applicant for ELECTRONIC STETHOSCOPE?

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

What is the FDA product code for ELECTRONIC STETHOSCOPE?

The FDA product code for ELECTRONIC STETHOSCOPE 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

Other records listing Sharp Corporation 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.

K113865PULTOL

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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