Cleared Traditional

Stethophone

K231551 · Sparrow Acoustics, Inc. · Cardiovascular

Oct 2023

Decision

135d

Days

Class 2

Risk

About This 510(k) Submission

K231551 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 October 12, 2023, 135 days after receiving the submission on May 30, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1875.

Submission Details

510(k) Number	K231551 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 30, 2023
Decision Date	October 12, 2023
Days to Decision	135 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF