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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 K844023
Device Name AQUAFORM ELECTRODES WITH AQUAPORE
Applicant
Biostim, Inc.
P.O. Box 127
Brooksville,  FL  33512
Applicant Contact ALAN P SCHWARTZ
Correspondent
Biostim, Inc.
P.O. Box 127
Brooksville,  FL  33512
Correspondent Contact ALAN P SCHWARTZ
Regulation Number882.1320
Classification Product Code
GXY  
Date Received10/15/1984
Decision Date 02/01/1985
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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