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FDA 510(k)

Electronic Stethoscope DS301

K-Number: K160023 · 2016-09-30

ApplicantImediplus, Inc.
Decision Date2016-09-30
Product CodeDQD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Electronic Stethoscope DS301 is the device name listed in this FDA 510(k) record. The listed applicant is Imediplus, Inc.. It received FDA 510(k) clearance on 2016-09-30 under 510(k) number K160023. 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 DS301?

Electronic Stethoscope DS301 is a medical device that received FDA 510(k) clearance on 2016-09-30. The listed applicant is Imediplus, Inc.. The 510(k) number is K160023.

When did Electronic Stethoscope DS301 receive FDA 510(k) clearance?

Electronic Stethoscope DS301 received FDA 510(k) clearance on 2016-09-30, under 510(k) number K160023.

Who is the listed applicant for Electronic Stethoscope DS301?

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

What is the FDA product code for Electronic Stethoscope DS301?

The FDA product code for Electronic Stethoscope DS301 is DQD.

Other records listing Imediplus, Inc. 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.

K182196Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-StethK173663Electronic Stethoscope DS3011A

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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