Cleared Traditional

K162589 - Adscope 658 Electronic Stethoscope
(FDA 510(k) Clearance)

K162589 · American Diagnostic Corp. · Cardiovascular

Mar 2017

Decision

175d

Days

Class 2

Risk

K162589 is an FDA 510(k) clearance for the Adscope 658 Electronic Stethoscope. This device is classified as a Stethoscope, Electronic (Class II — Special Controls, product code DQD).

Submitted by American Diagnostic Corp. (Hauppauge, US). The FDA issued a Cleared decision on March 10, 2017, 175 days after receiving the submission on September 16, 2016.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1875.

Submission Details

510(k) Number	K162589 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 16, 2016
Decision Date	March 10, 2017
Days to Decision	175 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Statement