Cleared Traditional

K914100 - STETHOSCOPE
(FDA 510(k) Clearance)

K914100 · Atlas Medical Products, Inc. · Cardiovascular device

Nov 1991

Decision

56d

Days

Class 1

Risk

K914100 is an FDA 510(k) clearance for the STETHOSCOPE. This device is classified as a Stethoscope, Manual (Class I - General Controls, product code LDE).

Submitted by Atlas Medical Products, Inc. (Stone Mountain, US). The FDA issued a Cleared decision on November 7, 1991, 56 days after receiving the submission on September 12, 1991.

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

Submission Details

510(k) Number	K914100 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 12, 1991
Decision Date	November 07, 1991
Days to Decision	56 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Statement