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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 K871441
Device Name ELECTRODE RTE-3, CLIP-ON DIAGNOSTIC ELECTRODE
Applicant
Nitto Denko America, Inc.
55 Nicholson Ln.
San Jose,  CA  95134
Applicant Contact KOGAMI
Correspondent
Nitto Denko America, Inc.
55 Nicholson Ln.
San Jose,  CA  95134
Correspondent Contact KOGAMI
Regulation Number870.2360
Classification Product Code
DRX  
Date Received04/13/1987
Decision Date 08/03/1987
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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