Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Heroic Faith International , Ltd.. It received FDA 510(k) clearance on 2024-11-25 under approval 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. It is manufactured by Heroic Faith International , Ltd.. The 510(k) number is K242971.

When was AccurSound Electronic Stethoscope (AS101) approved by the FDA?

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

What company makes AccurSound Electronic Stethoscope (AS101)?

AccurSound Electronic Stethoscope (AS101) is manufactured by Heroic Faith International , Ltd..

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

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

Related Clinical Trials

NCT07568795 Clinical Validation of Portable Electronic Stethoscope for Detecting VHD RECRUITING NCT06734793 Wearable Electronic Breath Sound Sensing Device RECRUITING

Other Devices by Heroic Faith International , Ltd.

K221805AccurSound Electronic Stethoscope AS-101 K242798Airmod

Related Devices (Code: DQD)

K160401Tyto StethoscopeTyto Care , Ltd. K160023Electronic Stethoscope DS301Imediplus, Inc. K160016Steth IOStratoscientific, Inc. K172296Stethee ProM3Dicine Pty , Ltd. K170928CADence SystemAum Cardiovascular, Inc. K170874Eko Model E5 System (EME5), Eko DUOEko Devices, Inc.

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.

↑