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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Photic, Evoked Response
510(k) Number K043491
Device Name ENFANTTM
Applicant
Diopsys, Inc.
16 Chapin Rd. Suite 911
P.O. Box 672
Pine Brook,  NJ  07058
Applicant Contact JOSEPH FONTANETTA
Correspondent
Diopsys, Inc.
16 Chapin Rd. Suite 911
P.O. Box 672
Pine Brook,  NJ  07058
Correspondent Contact JOSEPH FONTANETTA
Regulation Number882.1890
Classification Product Code
GWE  
Date Received12/17/2004
Decision Date 03/16/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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