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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 K922270
Device Name PHYSIOTECH 4000 OR NORODYN 8000
Applicant
Myo-Tronics, Inc.
720 Olive Way Suite 800
Seattle,  WA  98101
Applicant Contact ADIB
Correspondent
Myo-Tronics, Inc.
720 Olive Way Suite 800
Seattle,  WA  98101
Correspondent Contact ADIB
Regulation Number882.5050
Classification Product Code
HCC  
Date Received05/14/1992
Decision Date 09/02/1994
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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