AccurSound Electronic Stethoscope (AS101)— 510(k) K242971

Name: FDA 510(k) clearance K242971
Creator: U.S. Food and Drug Administration
Published: 2024-11-25

Substantially Equivalent

Heroic Faith International , Ltd.

FDA 510(k) clearance K242971 for AccurSound Electronic Stethoscope (AS101), Substantially Equivalent on 2024-11-25. Applicant: Heroic Faith International , Ltd.. Device class: 2.

Clearance details

Applicant: Heroic Faith International , Ltd.
Product code: Code DQD
Device class: Class 2
Regulation: 21 CFR 870.1875
Advisory panel: Cardiovascular
Date received: 2024-09-26
Decision date: 2024-11-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei, TW

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.