Cleared Traditional

K924095 - TIMEOSCOPE AND FLEXISCOPE
(FDA 510(k) Clearance)

K924095 · Stethoscopes of America, Inc. · Cardiovascular device

Oct 1992

Decision

68d

Days

Class 1

Risk

K924095 is an FDA 510(k) clearance for the TIMEOSCOPE AND FLEXISCOPE. This device is classified as a Stethoscope, Manual (Class I - General Controls, product code LDE).

Submitted by Stethoscopes of America, Inc. (Stone Mountain, US). The FDA issued a Cleared decision on October 20, 1992, 68 days after receiving the submission on August 13, 1992.

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

Submission Details

510(k) Number	K924095 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 13, 1992
Decision Date	October 20, 1992
Days to Decision	68 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Statement