Cleared Special

K062976 - MODIFICATION TO CIC PRO CLINICAL INFORM...

K062976 is an FDA 510(k) clearance for MODIFICATION TO CIC PRO CLINICAL INFORM..., manufactured by Ge Medical Systems Information Technologies. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Special 510(k) pathway after a 168-day FDA review.

K062976 · Ge Medical Systems Information Technologies · Cardiovascular device
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Mar 2007
Decision
168d
Days
Class 2
Risk

K062976 is an FDA 510(k) clearance for the MODIFICATION TO CIC PRO CLINICAL INFORMATION CENTER. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Ge Medical Systems Information Technologies (Milwaukee, US). The FDA issued a Cleared decision on March 16, 2007 after a review of 168 days - an extended review 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. 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 - K062976

510(k) Number K062976 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2006
Decision Date March 16, 2007
Days to Decision 168 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
43d slower than avg
Panel avg: 125d · This submission: 168d
Pathway characteristics
Modification to existing cleared device.

DSI Device Classification - Class 2, Special Controls

Product Code DSI Detector And Alarm, Arrhythmia
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 - DSI Detector And Alarm, Arrhythmia

All 238
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