Cleared Special

K060833 - 12SL ECG ANALYSIS PROGRAM

K060833 is an FDA 510(k) clearance for 12SL ECG ANALYSIS PROGRAM, manufactured by Ge Medical Systems Information Technologies. The device is a Class 2 Cardiovascular device with product code MHX cleared through the Special 510(k) pathway after a 127-day FDA review.

K060833 · Ge Medical Systems Information Technologies · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2006
Decision
127d
Days
Class 2
Risk

K060833 is an FDA 510(k) clearance for the 12SL ECG ANALYSIS PROGRAM. Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by Ge Medical Systems Information Technologies (Milwaukee, US). The FDA issued a Cleared decision on August 1, 2006 after a review of 127 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. 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. Standard predicate reliance. 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 Medical Systems Information Technologies devices

FDA 510(k) Submission Details - K060833

510(k) Number K060833 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 2006
Decision Date August 01, 2006
Days to Decision 127 days
Submission Type Special
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
2d slower than avg
Panel avg: 125d · This submission: 127d
Pathway characteristics
Modification to existing cleared device.

MHX Device Classification - Class 2, Special Controls

Product Code MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
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 - MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

All 319
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K060833.
PHILIPS MP5 INTELLIVUE PATIENT MONITOR
K062392 · Philips Medizin Systeme Boeblingen GmbH · Sep 2006
PHILIPS MODEL MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90 INTELLIVUE PATIENT MONITORS
K061610 · Philips Medizin Systeme Boeblingen GmbH · Aug 2006
VISION VXC CENTRAL STATION, MODEL 4300
K061675 · Invivo Corporation · Aug 2006
VS-800 VITAL SIGNS MONITOR
K060281 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jun 2006
THE PHILIPS INTELLIVUE PATIENT MONITORS, MODELS MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90
K061052 · Philips Medical Systems North America, Inc. · May 2006
MORTARA SURVEYOR TELEMETRY CENTRAL STATION
K060135 · Mortara Instrument, Inc. · May 2006