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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 K832122
Device Name ENRAF NONIVS2 CHANNEL EMG/TEMP. FEED
Applicant
FLUIDOTHERAPY CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
FLUIDOTHERAPY CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number882.5050
Classification Product Code
HCC  
Date Received06/30/1983
Decision Date 08/12/1983
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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