Cleared Traditional

Stethophone v1

K222871 · Sparrow Acoustics, Inc. · Cardiovascular

Mar 2023

Decision

188d

Days

Class 2

Risk

About This 510(k) Submission

K222871 is an FDA 510(k) clearance for the Stethophone v1, a Stethoscope, Electronic (Class II — Special Controls, product code DQD), submitted by Sparrow Acoustics, Inc. (Lucasville, CA). The FDA issued a Cleared decision on March 29, 2023, 188 days after receiving the submission on September 22, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1875.

Submission Details

510(k) Number	K222871 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 22, 2022
Decision Date	March 29, 2023
Days to Decision	188 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF