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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 K924473
Device Name DISPOSABLE THERAPY ELECTRODE
Applicant
Zimmer Elektromedizin GmbH
25 Mauchly, Suite 300
Irvine,  CA  92718
Applicant Contact DAL MOLIN
Correspondent
Zimmer Elektromedizin GmbH
25 Mauchly, Suite 300
Irvine,  CA  92718
Correspondent Contact DAL MOLIN
Regulation Number882.1320
Classification Product Code
GXY  
Date Received08/31/1992
Decision Date 05/19/1993
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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