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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Full-Montage Standard Electroencephalograph
510(k) Number K953449
Device Name MODEL 1207, HYDRODOT NEUROMONITORING SYSTEM ADHESIVE PADS
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 Number882.1400
Classification Product Code
GWQ  
Date Received07/18/1995
Decision Date 10/12/1995
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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