Home / 510(k) Clearances / K061907

510(k) K061907

MODIFICATION TO: DATEX-OHMEDA S/5 ENTROPY MODULE, E-ENTROPY AND ACCESSORIES by Ge Healthcare — Product Code OLW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 2008
Date Received
July 5, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Index-Generating Electroencephalograph Software
Device Class
Class II
Regulation Number
882.1400
Review Panel
NE
Submission Type

Analyze electrical activity of the brain by transformation of electroencephalograph signals into a dimensionless index number for use and interpretation by a qualified user.

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