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FDA 510(k)

Stethophone Pro

K-Number: K252595 · 2025-09-12

ApplicantSparrow Acoustics, Inc.
Decision Date2025-09-12
Product CodeDQD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Stethophone Pro 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 2025-09-12 under 510(k) number K252595. 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 Pro?

Stethophone Pro is a medical device that received FDA 510(k) clearance on 2025-09-12. The listed applicant is Sparrow Acoustics, Inc.. The 510(k) number is K252595.

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

Stethophone Pro received FDA 510(k) clearance on 2025-09-12, under 510(k) number K252595.

Who is the listed applicant for Stethophone Pro?

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 Pro?

The FDA product code for Stethophone Pro 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.

K240901StethophoneK231551StethophoneK222871Stethophone v1

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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