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FDA 510(k)

Stethophone v1

K-Number: K222871 · 2023-03-29

ApplicantSparrow Acoustics, Inc.
Decision Date2023-03-29
Product CodeDQD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Stethophone v1 is the device name listed in this FDA 510(k) record. The listed applicant is Sparrow Acoustics, Inc.. It received FDA 510(k) clearance on 2023-03-29 under 510(k) number K222871. 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 Stethophone v1?

Stethophone v1 is a medical device that received FDA 510(k) clearance on 2023-03-29. The listed applicant is Sparrow Acoustics, Inc.. The 510(k) number is K222871.

When did Stethophone v1 receive FDA 510(k) clearance?

Stethophone v1 received FDA 510(k) clearance on 2023-03-29, under 510(k) number K222871.

Who is the listed applicant for Stethophone v1?

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

What is the FDA product code for Stethophone v1?

The FDA product code for Stethophone v1 is DQD.

Other records listing Sparrow Acoustics, 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.

K252595Stethophone ProK240901StethophoneK231551Stethophone

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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