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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Electrocardiograph
510(k) Number K862618
Device Name SKINTACT AG ELECTRODES
Applicant
Leon H. Lang Co.
6010 Innsbruck
Austria
Archenweg, 56,  AT
Applicant Contact LEONHARD LANG
Correspondent
Leon H. Lang Co.
6010 Innsbruck
Austria
Archenweg, 56,  AT
Correspondent Contact LEONHARD LANG
Regulation Number870.2360
Classification Product Code
DRX  
Date Received07/09/1986
Decision Date 09/15/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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