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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Communication, Powered
510(k) Number K863995
Device Name KEYNOTE
Applicant
Sensory Aids Corp.
205 W. Grand Ave.,
Suite 122
Bensenville,  IL  60106
Applicant Contact RON B MERRICK
Correspondent
Sensory Aids Corp.
205 W. Grand Ave.,
Suite 122
Bensenville,  IL  60106
Correspondent Contact RON B MERRICK
Regulation Number890.3710
Classification Product Code
ILQ  
Date Received10/14/1986
Decision Date 11/13/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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