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510(k) K081151

COMPUMEDICS NEUVO by Compumedics USA, Ltd. — Product Code GWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 2008
Date Received
April 23, 2008
Clearance Type
Special
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Full-Montage Standard Electroencephalograph
Device Class
Class II
Regulation Number
882.1400
Review Panel
NE
Submission Type

Acquire, display, store, and archive electroencephalographic signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations

Other clearances by Compumedics USA, Ltd.

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