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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 K894044
Device Name ACTILLUME
Applicant
Ambulatory Monitoring, Inc.
731 Saw Mill River Rd.
Ardsley,  NY  10502
Applicant Contact WILLIAM GRUEN
Correspondent
Ambulatory Monitoring, Inc.
731 Saw Mill River Rd.
Ardsley,  NY  10502
Correspondent Contact WILLIAM GRUEN
Regulation Number882.1400
Classification Product Code
GWQ  
Date Received06/07/1989
Decision Date 12/22/1989
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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