Cleared Abbreviated

QUINTON Q-STRESS, MODEL 000483

K001492 · Quinton, Inc. · Cardiovascular
Aug 2000
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K001492 is an FDA 510(k) clearance for the QUINTON Q-STRESS, MODEL 000483, a Electrocardiograph (Class II — Special Controls, product code DPS), submitted by Quinton, Inc. (Bothell, US). The FDA issued a Cleared decision on August 9, 2000, 89 days after receiving the submission on May 12, 2000. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2340.

Submission Details

510(k) Number K001492 FDA.gov
FDA Decision Cleared SESE
Date Received May 12, 2000
Decision Date August 09, 2000
Days to Decision 89 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

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