Cleared Traditional

K935944 - PROSCOPES AND ADSCOPES
(FDA 510(k) Clearance)

K935944 · American Diagnostic Corp. · Cardiovascular device

Mar 1994

Decision

80d

Days

Class 1

Risk

K935944 is an FDA 510(k) clearance for the PROSCOPES AND ADSCOPES. This device is classified as a Stethoscope, Manual (Class I - General Controls, product code LDE).

Submitted by American Diagnostic Corp. (West Babylon, US). The FDA issued a Cleared decision on March 3, 1994, 80 days after receiving the submission on December 13, 1993.

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

Submission Details

510(k) Number	K935944 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 13, 1993
Decision Date	March 03, 1994
Days to Decision	80 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Statement