Cleared Traditional

K103765 - MAC 600 RESTING ECG ANALYSIS SYSTEM

K103765 is an FDA 510(k) clearance for MAC 600 RESTING ECG ANALYSIS SYSTEM, manufactured by Ge Medical Systems Information Technologies, Inc.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K103765 · Ge Medical Systems Information Technologies, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2011
Decision
145d
Days
Class 2
Risk

K103765 is an FDA 510(k) clearance for the MAC 600 RESTING ECG ANALYSIS SYSTEM. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Ge Medical Systems Information Technologies, Inc. (Wauwatosa, US). The FDA issued a Cleared decision on May 17, 2011 after a review of 145 days - within the typical 510(k) review window.

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 Ge Medical Systems Information Technologies, Inc. devices

FDA 510(k) Submission Details - K103765

510(k) Number K103765 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2010
Decision Date May 17, 2011
Days to Decision 145 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 125d · This submission: 145d
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 279
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K103765.
PAGEWRITER TC 20, 30, 50, 70
K113144 · Philips Medical Systems · Apr 2012
ELECTROCARDIOGRAPH
K120188 · Edan Instruments, Inc. · Mar 2012
ACG-8511 PORTABLE ECG MONITOR
K110328 · Andon Health Co, Ltd. · Jul 2011
MAC 5500 HD, MAC 3500
K110266 · Ge Medical Systems Information Technologies, Inc. · Apr 2011
V-TRUST MODEL TD-2202 PORTABLE ECG RECORDER
K101569 · Taidoc Technology Corporation · Mar 2011
ELI 10 ELECTROCARDIOGRAPH MODEL ELI 10
K102206 · Mortara Instrument, Inc. · Feb 2011