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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 K863956
Device Name MACULOSCOPE(TM)
Applicant
Doran Instruments, Inc.
410 Great Rd.
P.O. Box 1070
Littleton,  MA  01460
Applicant Contact BRUCE DORAN
Correspondent
Doran Instruments, Inc.
410 Great Rd.
P.O. Box 1070
Littleton,  MA  01460
Correspondent Contact BRUCE DORAN
Regulation Number882.1890
Classification Product Code
GWE  
Date Received10/10/1986
Decision Date 11/13/1986
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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