Cleared Traditional

Stethophone

K240901 · Sparrow Acoustics, Inc. · Cardiovascular

Sep 2024

Decision

170d

Days

Class 2

Risk

About This 510(k) Submission

K240901 is an FDA 510(k) clearance for the Stethophone, a Stethoscope, Electronic (Class II — Special Controls, product code DQD), submitted by Sparrow Acoustics, Inc. (Lucasville, CA). The FDA issued a Cleared decision on September 19, 2024, 170 days after receiving the submission on April 2, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1875.

Submission Details

510(k) Number	K240901 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 02, 2024
Decision Date	September 19, 2024
Days to Decision	170 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF