Cleared Abbreviated

Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 000503

K003576 · Quinton, Inc. · Cardiovascular
Jan 2001
Decision
66d
Days
Class 2
Risk

About This 510(k) Submission

K003576 is an FDA 510(k) clearance for the Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 000503, a Detector And Alarm, Arrhythmia (Class II — Special Controls, product code DSI), submitted by Quinton, Inc. (Bothell, US). The FDA issued a Cleared decision on January 25, 2001, 66 days after receiving the submission on November 20, 2000. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K003576 FDA.gov
FDA Decision Cleared SESE
Date Received November 20, 2000
Decision Date January 25, 2001
Days to Decision 66 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DSI — Detector And Alarm, Arrhythmia
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1025

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