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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 K850849
Device Name MYOMETER EMG BIOFEEDBACK DEVICE
Applicant
PHYSIO TECHNOLOGY, INC.
1925 W. 6TH ST.
TOPEKA,  KS  66606
Applicant Contact JAMES G BAUMANN
Correspondent
PHYSIO TECHNOLOGY, INC.
1925 W. 6TH ST.
TOPEKA,  KS  66606
Correspondent Contact JAMES G BAUMANN
Regulation Number882.5050
Classification Product Code
HCC  
Date Received03/01/1985
Decision Date 05/31/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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