Cleared Traditional

EP AMP, MODEL #901

K925346 · Quinton Electrophysiology Corp. · Cardiovascular

Apr 1993

Decision

190d

Days

Class 2

Risk

About This 510(k) Submission

K925346 is an FDA 510(k) clearance for the EP AMP, MODEL #901, a Amplifier And Signal Conditioner, Biopotential (Class II — Special Controls, product code DRR), submitted by Quinton Electrophysiology Corp. (Markham, Ontario, CA). The FDA issued a Cleared decision on April 30, 1993, 190 days after receiving the submission on October 22, 1992. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2050.

Submission Details

510(k) Number	K925346 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 22, 1992
Decision Date	April 30, 1993
Days to Decision	190 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Statement