Cleared Traditional

K971570 - EPXPRESS SYSTEM (TIMBERWOLF REVISION) /000391
(FDA 510(k) Clearance)

K971570 · Quinton Electrophysiology Corp. · Cardiovascular

Dec 1997

Decision

244d

Days

Class 2

Risk

K971570 is an FDA 510(k) clearance for the EPXPRESS SYSTEM (TIMBERWOLF REVISION) /000391. This device is classified as a Amplifier And Signal Conditioner, Biopotential (Class II — Special Controls, product code DRR).

Submitted by Quinton Electrophysiology Corp. (Bothell, US). The FDA issued a Cleared decision on December 29, 1997, 244 days after receiving the submission on April 29, 1997.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2050.

Submission Details

510(k) Number	K971570 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 29, 1997
Decision Date	December 29, 1997
Days to Decision	244 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF