Cleared Traditional

AccurSound Electronic Stethoscope (AS101)

K242971 · Heroic Faith International , Ltd. · Cardiovascular
Nov 2024
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K242971 is an FDA 510(k) clearance for the AccurSound Electronic Stethoscope (AS101), a Stethoscope, Electronic (Class II — Special Controls, product code DQD), submitted by Heroic Faith International , Ltd. (Taipei, TW). The FDA issued a Cleared decision on November 25, 2024, 60 days after receiving the submission on September 26, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1875.

Submission Details

510(k) Number K242971 FDA.gov
FDA Decision Cleared SESE
Date Received September 26, 2024
Decision Date November 25, 2024
Days to Decision 60 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQD — Stethoscope, Electronic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1875