FDA 510(k)

HD Steth

K-Number: K201299 · 2020-07-10

Decision Date2020-07-10

Product CodeDQD

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

HD Steth is the device name listed in this FDA 510(k) record. The listed applicant is Hd Medical, Inc.. It received FDA 510(k) clearance on 2020-07-10 under 510(k) number K201299. 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 HD Steth?

HD Steth is a medical device that received FDA 510(k) clearance on 2020-07-10. The listed applicant is Hd Medical, Inc.. The 510(k) number is K201299.

When did HD Steth receive FDA 510(k) clearance?

HD Steth received FDA 510(k) clearance on 2020-07-10, under 510(k) number K201299.

Who is the listed applicant for HD Steth?

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

What is the FDA product code for HD Steth?

The FDA product code for HD Steth 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.