Cleared Special

K073625 - MODIFICATION TO: MAC 5500 RESTING ECG A...

K073625 is the FDA 510(k) clearance for MODIFICATION TO: MAC 5500 RESTING ECG A... by Ge Healthcare Systems Information Technologies. It is a Class 2 Cardiovascular device (product code DPS) cleared through the Special 510(k) pathway after a 30-day FDA review.

K073625 · Ge Healthcare Systems Information Technologies · Cardiovascular device
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Jan 2008
Decision
30d
Days
Class 2
Risk

K073625 is an FDA 510(k) clearance for the MODIFICATION TO: MAC 5500 RESTING ECG ANALYSIS SYSTEM. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Ge Healthcare Systems Information Technologies (Wauwatosa, US). The FDA issued a Cleared decision on January 25, 2008 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ge Healthcare Systems Information Technologies devices

Submission Details

510(k) Number K073625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2007
Decision Date January 25, 2008
Days to Decision 30 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 248
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K073625.
MORTARA ELI 350 ELECTROCARDIOGRAPH
K082946 · Mortara Instrument, Inc. · Dec 2008
MAC 1600 ECG ANALYSIS SYSTEM
K081437 · Ge Medical Systems Information Technologies · Jul 2008
PAGEWRITER CARDIOGRAPH
K080999 · Philips Medical Systems · May 2008
CP100 & 200 12-LEAD RESTING ELECTROCARDIOGRAPHS
K072449 · Welch Allyn, Inc. · Nov 2007
ECG-1250A SERIES CARDIOFAX S AND ECG-1350A SERIES CARDIOFAX M
K072217 · Nihon Kohden America, Inc. · Aug 2007
QP-156E ECG EXERCISE TEST OPTION FOR THE ECG-1500A SERIES/CARDIOFAX V
K072060 · Nihon Kohden America, Inc. · Aug 2007