AccurSound Electronic Stethoscope AS-101— 510(k) K221805

Name: FDA 510(k) clearance K221805
Creator: U.S. Food and Drug Administration
Published: 2023-03-23

Substantially Equivalent

Heroic Faith International , Ltd.

FDA 510(k) clearance K221805 for AccurSound Electronic Stethoscope AS-101, Substantially Equivalent on 2023-03-23. 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: 2022-06-22
Decision date: 2023-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei City, 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.