510(k) K133882

CARESCAPE CENTRAL STATION (FORMALLY KNOWN AS CIC PRO) by Ge Medical Systems Information Technologies, Inc. — Product Code DXJ

K133882 is an FDA 510(k) premarket notification submitted by Ge Medical Systems Information Technologies, Inc. for the device "CARESCAPE CENTRAL STATION (FORMALLY KNOWN AS CIC PRO)". The FDA issued a decision of Substantially Equivalent on April 30, 2014. The device falls under product code DXJ (Display, Cathode-Ray Tube, Medical), a Class II device regulated under 21 CFR 870.2450. Ge Medical Systems Information Technologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 2014
Date Received
December 20, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Display, Cathode-Ray Tube, Medical
Device Class
Class II
Regulation Number
870.2450
Review Panel
CV
Submission Type