Cleared Traditional

Q-TEL TELEMETRY SYSTEM V. 6.0 (ST)

K992908 · Quinton, Inc. · Cardiovascular
Mar 2000
Decision
189d
Days
Class 2
Risk

About This 510(k) Submission

K992908 is an FDA 510(k) clearance for the Q-TEL TELEMETRY SYSTEM V. 6.0 (ST), 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 March 6, 2000, 189 days after receiving the submission on August 30, 1999. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K992908 FDA.gov
FDA Decision Cleared SESE
Date Received August 30, 1999
Decision Date March 06, 2000
Days to Decision 189 days
Submission Type Traditional
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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