Cleared Traditional

Q-SMART HOLTER SYSTEMS

K910808 · Quinton, Inc. · Cardiovascular
Jul 1991
Decision
141d
Days
Class 2
Risk

About This 510(k) Submission

K910808 is an FDA 510(k) clearance for the Q-SMART HOLTER SYSTEMS, a Detector And Alarm, Arrhythmia (Class II — Special Controls, product code DSI), submitted by Quinton, Inc. (Seattle, US). The FDA issued a Cleared decision on July 17, 1991, 141 days after receiving the submission on February 26, 1991. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K910808 FDA.gov
FDA Decision Cleared SESE
Date Received February 26, 1991
Decision Date July 17, 1991
Days to Decision 141 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary —

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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