Cleared Special

K033964 - SOLAR 9500 INFORMATION MONITOR

K033964 is an FDA 510(k) clearance for SOLAR 9500 INFORMATION MONITOR, 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 24-day FDA review.

K033964 · Ge Medical Systems Information Technologies · Cardiovascular device
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Jan 2004
Decision
24d
Days
Class 2
Risk

K033964 is an FDA 510(k) clearance for the SOLAR 9500 INFORMATION MONITOR. 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 January 15, 2004 after a review of 24 days - a notably fast clearance cycle.

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. 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 Medical Systems Information Technologies devices

FDA 510(k) Submission Details - K033964

510(k) Number K033964 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2003
Decision Date January 15, 2004
Days to Decision 24 days
Submission Type Special
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
101d faster than avg
Panel avg: 125d · This submission: 24d
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 K033964.
M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.O AND THE M4840A TELEMETRY MONITORING SYSTEM II
K040357 · Philips Medical Systems, Inc. · Mar 2004
PHILIPS INTELLIVUE PATIENT MONITOR, MODELS MP40 & MP50
K040304 · Philips Medizin Systeme Boeblingen GmbH · Mar 2004
ENVOY PATIENT MONITOR
K030722 · Mennen Medical, Inc. · Feb 2004
INFINITY GAMMAXL
K033600 · Draeger Medical Systems, Inc. · Dec 2003
POLARIS 95000-A BEDSIDE/TRANSPORT MONITOR
K031124 · Datex-Ohmeda, Inc. · Dec 2003
SIEMENS INFINITY MODULAR MONITORS, MODELS SC 8000, SC 7000 AND SC 9000XL, WITH SCIO
K031340 · Siemens Medical Solutions USA, Inc. · Nov 2003