Cleared Traditional

AccurSound Electronic Stethoscope AS-101

K221805 · Heroic Faith International , Ltd. · Cardiovascular

Mar 2023

Decision

274d

Days

Class 2

Risk

About This 510(k) Submission

K221805 is an FDA 510(k) clearance for the AccurSound Electronic Stethoscope AS-101, a Stethoscope, Electronic (Class II — Special Controls, product code DQD), submitted by Heroic Faith International , Ltd. (Taipei City, TW). The FDA issued a Cleared decision on March 23, 2023, 274 days after receiving the submission on June 22, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1875.

Submission Details

510(k) Number	K221805 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 22, 2022
Decision Date	March 23, 2023
Days to Decision	274 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF