Cleared Traditional

Q4500 STREE TEST MONITOR

K910017 · Quinton, Inc. · Cardiovascular
Nov 1991
Decision
306d
Days
Class 2
Risk

About This 510(k) Submission

K910017 is an FDA 510(k) clearance for the Q4500 STREE TEST MONITOR, a Electrocardiograph (Class II — Special Controls, product code DPS), submitted by Quinton, Inc. (Seattle, US). The FDA issued a Cleared decision on November 5, 1991, 306 days after receiving the submission on January 3, 1991. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2340.

Submission Details

510(k) Number K910017 FDA.gov
FDA Decision Cleared SESE
Date Received January 03, 1991
Decision Date November 05, 1991
Days to Decision 306 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary —

Device Classification

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