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FDA 510(k)

Adscope 658 Electronic Stethoscope

K-Number: K162589 · 2017-03-10

ApplicantAmerican Diagnostic Corp.
Decision Date2017-03-10
Product CodeDQD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Adscope 658 Electronic Stethoscope is the device name listed in this FDA 510(k) record. The listed applicant is American Diagnostic Corp.. It received FDA 510(k) clearance on 2017-03-10 under 510(k) number K162589. 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 Adscope 658 Electronic Stethoscope?

Adscope 658 Electronic Stethoscope is a medical device that received FDA 510(k) clearance on 2017-03-10. The listed applicant is American Diagnostic Corp.. The 510(k) number is K162589.

When did Adscope 658 Electronic Stethoscope receive FDA 510(k) clearance?

Adscope 658 Electronic Stethoscope received FDA 510(k) clearance on 2017-03-10, under 510(k) number K162589.

Who is the listed applicant for Adscope 658 Electronic Stethoscope?

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

What is the FDA product code for Adscope 658 Electronic Stethoscope?

The FDA product code for Adscope 658 Electronic Stethoscope is DQD.

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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