Cleared Traditional

QUINTON MODEL 710 STRESS ELECTROCARDIOGRAPH

K945626 · Quinton, Inc. · Cardiovascular
Jun 1995
Decision
224d
Days
Class 2
Risk

About This 510(k) Submission

K945626 is an FDA 510(k) clearance for the QUINTON MODEL 710 STRESS ELECTROCARDIOGRAPH, a Electrocardiograph (Class II — Special Controls, product code DPS), submitted by Quinton, Inc. (Bothell, US). The FDA issued a Cleared decision on June 28, 1995, 224 days after receiving the submission on November 16, 1994. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2340.

Submission Details

510(k) Number K945626 FDA.gov
FDA Decision Cleared SESE
Date Received November 16, 1994
Decision Date June 28, 1995
Days to Decision 224 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement

Device Classification

Product Code DPS — Electrocardiograph
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2340