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FDA 510(k)

Stethee Pro 1, Stethee Pro Software System

K-Number: K193631 · 2020-10-09

ApplicantM3Dicine Pty , Ltd.
Decision Date2020-10-09
Product CodeDQD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Stethee Pro 1, Stethee Pro Software System is the device name listed in this FDA 510(k) record. The listed applicant is M3Dicine Pty , Ltd.. It received FDA 510(k) clearance on 2020-10-09 under 510(k) number K193631. 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 Stethee Pro 1, Stethee Pro Software System?

Stethee Pro 1, Stethee Pro Software System is a medical device that received FDA 510(k) clearance on 2020-10-09. The listed applicant is M3Dicine Pty , Ltd.. The 510(k) number is K193631.

When did Stethee Pro 1, Stethee Pro Software System receive FDA 510(k) clearance?

Stethee Pro 1, Stethee Pro Software System received FDA 510(k) clearance on 2020-10-09, under 510(k) number K193631.

Who is the listed applicant for Stethee Pro 1, Stethee Pro Software System?

The FDA 510(k) record lists M3Dicine Pty , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Stethee Pro 1, Stethee Pro Software System?

The FDA product code for Stethee Pro 1, Stethee Pro Software System is DQD.

Other records listing M3Dicine Pty , Ltd. 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.

K172296Stethee Pro

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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