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510(k) K960732

HYDROSPOT EEG ELECTRODE MODEL 1501, HYDROSPOT LEADWIRE MODEL 1500 by Physiometrix, Inc. — Product Code GXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 1996
Date Received
February 22, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Cutaneous
Device Class
Class II
Regulation Number
882.1320
Review Panel
NE
Submission Type

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