510(k) K010164

ICG MODULE by General Electric Medical Systems Information Techn — Product Code DSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 2001
Date Received
January 18, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plethysmograph, Impedance
Device Class
Class II
Regulation Number
870.2770
Review Panel
CV
Submission Type