Cleared Traditional

CORE 500 Digital Stethoscope

K233609 · Eko Health, Inc. · Cardiovascular

Mar 2024

Decision

136d

Days

Class 2

Risk

About This 510(k) Submission

K233609 is an FDA 510(k) clearance for the CORE 500 Digital Stethoscope, a Stethoscope, Electronic (Class II — Special Controls, product code DQD), submitted by Eko Health, Inc. (Emeryville, US). The FDA issued a Cleared decision on March 28, 2024, 136 days after receiving the submission on November 13, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1875.

Submission Details

510(k) Number	K233609 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 13, 2023
Decision Date	March 28, 2024
Days to Decision	136 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF