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FDA 510(k)

AccurSound Electronic Stethoscope (AS101)

K-Number: K242971 · 2024-11-25

ApplicantHeroic Faith International , Ltd.
Decision Date2024-11-25
Product CodeDQD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AccurSound Electronic Stethoscope (AS101) is the device name listed in this FDA 510(k) record. The listed applicant is Heroic Faith International , Ltd.. It received FDA 510(k) clearance on 2024-11-25 under 510(k) number K242971. 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 AccurSound Electronic Stethoscope (AS101)?

AccurSound Electronic Stethoscope (AS101) is a medical device that received FDA 510(k) clearance on 2024-11-25. The listed applicant is Heroic Faith International , Ltd.. The 510(k) number is K242971.

When did AccurSound Electronic Stethoscope (AS101) receive FDA 510(k) clearance?

AccurSound Electronic Stethoscope (AS101) received FDA 510(k) clearance on 2024-11-25, under 510(k) number K242971.

Who is the listed applicant for AccurSound Electronic Stethoscope (AS101)?

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

What is the FDA product code for AccurSound Electronic Stethoscope (AS101)?

The FDA product code for AccurSound Electronic Stethoscope (AS101) is DQD.

Other records listing Heroic Faith International , 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.

K242798AirmodK221805AccurSound Electronic Stethoscope AS-101

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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