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510(k) K150298

Entropy Module, E-ENTROPY-01 by Ge Healthcare Filand OY — Product Code OLW

K150298 is an FDA 510(k) premarket notification submitted by Ge Healthcare Filand OY for the device "Entropy Module, E-ENTROPY-01". The FDA issued a decision of Substantially Equivalent on November 12, 2015. The device falls under product code OLW (Index-Generating Electroencephalograph Software), a Class II device regulated under 21 CFR 882.1400.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 2015
Date Received
February 6, 2015
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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FDA data resources