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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Aid, Vision, Electronic, Battery-Powered
510(k) Number K862338
Device Name SENSORY 6
Applicant
Brytech, Inc.
Box 8823
Ottawa, Ontario
Canada,  CA K1G 3J2
Applicant Contact BRYENTON
Correspondent
Brytech, Inc.
Box 8823
Ottawa, Ontario
Canada,  CA K1G 3J2
Correspondent Contact BRYENTON
Regulation Number886.5900
Classification Product Code
HPG  
Date Received06/20/1986
Decision Date 09/03/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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