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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Media, Electroconductive
510(k) Number K802658
Device Name RODEL ELECTRODERM PADS
Applicant
RODEL PRODUCTS CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
RODEL PRODUCTS CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number882.1275
Classification Product Code
GYB  
Date Received10/24/1980
Decision Date 12/30/1980
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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