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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Biofeedback
510(k) Number K894840
Device Name MYODAC2 BIOFEEDBACK DEVICE
Applicant
Thought Technology , Ltd.
2180 Belgrave Ave.
Montreal, Quebec,  CA H4A 2L8
Applicant Contact HAL K MYERS
Correspondent
Thought Technology , Ltd.
2180 Belgrave Ave.
Montreal, Quebec,  CA H4A 2L8
Correspondent Contact HAL K MYERS
Regulation Number882.5050
Classification Product Code
HCC  
Date Received07/20/1989
Decision Date 10/13/1989
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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