Cleared Abbreviated

PYRAMIS ECG MANAGEMENT SYSTEM MODEL NUMBERS, 92600 AND 92601

K032038 · Quinton, Inc. · Cardiovascular
Sep 2003
Decision
66d
Days
Class 2
Risk

About This 510(k) Submission

K032038 is an FDA 510(k) clearance for the PYRAMIS ECG MANAGEMENT SYSTEM MODEL NUMBERS, 92600 AND 92601, a Computer, Diagnostic, Programmable (Class II — Special Controls, product code DQK), submitted by Quinton, Inc. (Bothell, US). The FDA issued a Cleared decision on September 5, 2003, 66 days after receiving the submission on July 1, 2003. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K032038 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 2003
Decision Date September 05, 2003
Days to Decision 66 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQK — Computer, Diagnostic, Programmable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1425

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