Cleared Special

K071982 - MODIFICATION TO: UNITY NETWORK ID

K071982 is an FDA 510(k) clearance for MODIFICATION TO: UNITY NETWORK ID, manufactured by Ge Medical Systems Information Technologies. The device is a Class 2 Cardiovascular device with product code MWI cleared through the Special 510(k) pathway after a 64-day FDA review.

K071982 · Ge Medical Systems Information Technologies · Cardiovascular device
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Sep 2007
Decision
64d
Days
Class 2
Risk

K071982 is an FDA 510(k) clearance for the MODIFICATION TO: UNITY NETWORK ID. Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by Ge Medical Systems Information Technologies (Milwaukee, US). The FDA issued a Cleared decision on September 21, 2007 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - 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 - K071982

510(k) Number K071982 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2007
Decision Date September 21, 2007
Days to Decision 64 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
61d faster than avg
Panel avg: 125d · This submission: 64d
Pathway characteristics
Modification to existing cleared device.

MWI Device Classification - Class 2, Special Controls

Product Code MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 - MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

All 150
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