Cleared Traditional

K980362 - MRI COMPATIBLE MONITOR AND ACCESSORIES

K980362 is an FDA 510(k) clearance for MRI COMPATIBLE MONITOR AND ACCESSORIES, manufactured by Datex-Engstrom, Inc.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K980362 · Datex-Engstrom, Inc. · Cardiovascular device
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Jun 1998
Decision
152d
Days
Class 2
Risk

K980362 is an FDA 510(k) clearance for the MRI COMPATIBLE MONITOR AND ACCESSORIES. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Datex-Engstrom, Inc. (Tewksbury, US). The FDA issued a Cleared decision on June 30, 1998 after a review of 152 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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 - K980362

510(k) Number K980362 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1998
Decision Date June 30, 1998
Days to Decision 152 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
27d slower than avg
Panel avg: 125d · This submission: 152d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPS Device Classification - Class 2, Special Controls

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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 - DPS Electrocardiograph

All 333
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K980362.
CAMBRIDGE HEART CH 2000 CARDIAC DIAGNOSTIC SYSTEM
K981697 · Cambridge Heart, Inc. · Oct 1998
MICROMEDICAL 12 LEAD SIMULTANEOUS CABLE
K974220 · Micromedical, Inc. · Aug 1998
ANS 2000 ECG MONITOR AND RESPIRATION PACER
K973426 · D. E. Hokanson, Inc. · Aug 1998
EASY ECG PC BASED ELECTROCARDIOGRAPH
K972996 · Ates Medical S.R.L. · Apr 1998
BIOLOG 3000 ELECTROCARDIOGRAPH
K974351 · Micromedical, Inc. · Apr 1998
M1765A ECG MANAGER
K974746 · Hewlett-Packard Co. · Mar 1998