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FDA 510(k)

SIMULSCOPE AUSCULTATION AND SIMULSCOPE BEDSIDE AUSCULTATION SYSTEM

K-Number: K961937 · 1996-12-09

ApplicantDelphi Consulting Group
Decision Date1996-12-09
Product CodeDQD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SIMULSCOPE AUSCULTATION AND SIMULSCOPE BEDSIDE AUSCULTATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Delphi Consulting Group. It received FDA 510(k) clearance on 1996-12-09 under 510(k) number K961937. 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 SIMULSCOPE AUSCULTATION AND SIMULSCOPE BEDSIDE AUSCULTATION SYSTEM?

SIMULSCOPE AUSCULTATION AND SIMULSCOPE BEDSIDE AUSCULTATION SYSTEM is a medical device that received FDA 510(k) clearance on 1996-12-09. The listed applicant is Delphi Consulting Group. The 510(k) number is K961937.

When did SIMULSCOPE AUSCULTATION AND SIMULSCOPE BEDSIDE AUSCULTATION SYSTEM receive FDA 510(k) clearance?

SIMULSCOPE AUSCULTATION AND SIMULSCOPE BEDSIDE AUSCULTATION SYSTEM received FDA 510(k) clearance on 1996-12-09, under 510(k) number K961937.

Who is the listed applicant for SIMULSCOPE AUSCULTATION AND SIMULSCOPE BEDSIDE AUSCULTATION SYSTEM?

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

What is the FDA product code for SIMULSCOPE AUSCULTATION AND SIMULSCOPE BEDSIDE AUSCULTATION SYSTEM?

The FDA product code for SIMULSCOPE AUSCULTATION AND SIMULSCOPE BEDSIDE AUSCULTATION SYSTEM is DQD.

Related Clinical Trials

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Other records listing Delphi Consulting Group 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.

K983680TRINITY II SINGLE CHAMBER DVT PUMPK963957TRINITY DVT SYSTEMK970014TRINITY SLEEVES, HUNTLEIGH PUMP COMPATIBLE(T.B.D.)K961301E-SCOPE ELECTRONIC STETHOSCOPE MODEL 718-7120K954489TRINITY SLEEVE(S)

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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