Cleared Traditional

K974747 - CS/3 ARRHYTHMIA WORKSTATION

K974747 is an FDA 510(k) clearance for CS/3 ARRHYTHMIA WORKSTATION, manufactured by Datex-Engstrom, Inc.. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K974747 · Datex-Engstrom, Inc. · Cardiovascular device
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Apr 1998
Decision
125d
Days
Class 2
Risk

K974747 is an FDA 510(k) clearance for the CS/3 ARRHYTHMIA WORKSTATION. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Datex-Engstrom, Inc. (Tewksbury, US). The FDA issued a Cleared decision on April 23, 1998 after a review of 125 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Datex-Engstrom, Inc. devices

FDA 510(k) Submission Details - K974747

510(k) Number K974747 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1997
Decision Date April 23, 1998
Days to Decision 125 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 125d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSI Device Classification - Class 2, Special Controls

Product Code DSI Detector And Alarm, Arrhythmia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DSI Detector And Alarm, Arrhythmia

All 274
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K974747.
CS/3(TM) MONITORS*
K974792 · Datex-Engstrom, Inc. · Jun 1998
SPACELABS MEDICAL INTEGRATED MULTIPARAMETER MODULE 90496
K972502 · Spacelabs Medical, Inc. · May 1998
SIEMENS MULTIVIEW WORKSTATION ENHANCED WITH DIAGNOSTIC STATEMENTS (REST ECG)
K980625 · Siemens Medical Solutions USA, Inc. · May 1998
ENVOY PATIENT MONITOR
K974510 · Mennen Medical, Inc. · Apr 1998
MULTI-PARAMETER MODULE (M3000A)/DISPLAY UNIT (M3046A)
K971910 · Hewlett-Packard GmbH · Mar 1998
OBSERVER * CENTRAL STATION
K972498 · Johnson & Johnson Medical, Inc. · Feb 1998