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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cutaneous
510(k) Number K946318
Device Name MODEL 1001, HYDRODOT(TM) NEUROMONITORING SYSTEM WITH E NET(TM) EEG INTERFACE CABLE
Applicant
Physiometrix, Inc.
Five Billerica Park,
101 Billerica Ave.
North Billerica,  MA  01862
Applicant Contact DAWN E FRAZER
Correspondent
Physiometrix, Inc.
Five Billerica Park,
101 Billerica Ave.
North Billerica,  MA  01862
Correspondent Contact DAWN E FRAZER
Regulation Number882.1320
Classification Product Code
GXY  
Date Received12/28/1994
Decision Date 04/24/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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