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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 K812720
Device Name BODAI PATIENT COMMUNICATOR
Applicant
Sontek Industries, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Sontek Industries, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.3710
Classification Product Code
ILQ  
Date Received09/25/1981
Decision Date 11/05/1981
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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