Cleared Traditional

3 CHANNEL KNEE ELECTRONIC AMPLIFIED STETHOSCOPE

K991756 · Bio-Research Associates, Inc. · Cardiovascular

Dec 1999

Decision

200d

Days

Class 2

Risk

About This 510(k) Submission

K991756 is an FDA 510(k) clearance for the 3 CHANNEL KNEE ELECTRONIC AMPLIFIED STETHOSCOPE, a Stethoscope, Electronic (Class II — Special Controls, product code DQD), submitted by Bio-Research Associates, Inc. (Milwaukee, US). The FDA issued a Cleared decision on December 10, 1999, 200 days after receiving the submission on May 24, 1999. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1875.

Submission Details

510(k) Number	K991756 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 24, 1999
Decision Date	December 10, 1999
Days to Decision	200 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF