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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cutaneous
510(k) Number K922393
Device Name EMITENS ELECTRODES
Applicant
Electronic Monitors, Inc.
P.O. Box 1087
Euless,  TX  76039
Applicant Contact F. E WHITE
Correspondent
Electronic Monitors, Inc.
P.O. Box 1087
Euless,  TX  76039
Correspondent Contact F. E WHITE
Regulation Number882.1320
Classification Product Code
GXY  
Subsequent Product Code
GZJ  
Date Received05/20/1992
Decision Date 07/21/1993
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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