510(k) K970942

MODEL 1320, NEUROLINK II NEUROMONITORING SYSTEM by Physiometrix, Inc. — Product Code GWQ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 2, 1997
Date Received: March 14, 1997
Clearance Type: Traditional
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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