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510(k) K946318

MODEL 1001, HYDRODOT(TM) NEUROMONITORING SYSTEM WITH E NET(TM) EEG INTERFACE CABLE by Physiometrix, Inc. — Product Code GXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 1995
Date Received
December 28, 1994
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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