510(k) K001112

GE MARQUETTE CLINICAL INFORMATION CENTER, GE MARQUETTE CIC by General Electric Medical Systems Information Techn — Product Code DXJ

K001112 is an FDA 510(k) premarket notification submitted by General Electric Medical Systems Information Techn for the device "GE MARQUETTE CLINICAL INFORMATION CENTER, GE MARQUETTE CIC". The FDA issued a decision of Substantially Equivalent on June 14, 2000. The device falls under product code DXJ (Display, Cathode-Ray Tube, Medical), a Class II device regulated under 21 CFR 870.2450. General Electric Medical Systems Information Techn has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 2000
Date Received
April 6, 2000
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