510(k) K100683

NEUROLINK IP MODEL: PK1117 by Natus Medical Incorporated — Product Code GWQ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: April 9, 2010
Date Received: March 10, 2010
Clearance Type: Special
Expedited Review: No
Third Party Review: No

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

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