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FDA 510(k)

MEDITRON II THESTERTHOSCOPE SYSTEM

K-Number: K013725 · 2002-01-30

ApplicantMeditron AS
Decision Date2002-01-30
Product CodeDQD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MEDITRON II THESTERTHOSCOPE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Meditron AS. It received FDA 510(k) clearance on 2002-01-30 under 510(k) number K013725. 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 MEDITRON II THESTERTHOSCOPE SYSTEM?

MEDITRON II THESTERTHOSCOPE SYSTEM is a medical device that received FDA 510(k) clearance on 2002-01-30. The listed applicant is Meditron AS. The 510(k) number is K013725.

When did MEDITRON II THESTERTHOSCOPE SYSTEM receive FDA 510(k) clearance?

MEDITRON II THESTERTHOSCOPE SYSTEM received FDA 510(k) clearance on 2002-01-30, under 510(k) number K013725.

Who is the listed applicant for MEDITRON II THESTERTHOSCOPE SYSTEM?

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

What is the FDA product code for MEDITRON II THESTERTHOSCOPE SYSTEM?

The FDA product code for MEDITRON II THESTERTHOSCOPE SYSTEM 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 Meditron AS 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.

K991367MEDITRON STETHOSCOPE SYSTEM

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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