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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dc-Defibrillator, Low-Energy, (Including Paddles)
510(k) Number K872793
Device Name DP-700 NIKMAN DEFIB-PADS
Applicant
Nikomed U.S.A., Inc.
Hillsboro Business Center
Ilene Ct. - Bldg. 8
Belle Mead,  NJ  08502
Applicant Contact DONALD C EPSTEIN
Correspondent
Nikomed U.S.A., Inc.
Hillsboro Business Center
Ilene Ct. - Bldg. 8
Belle Mead,  NJ  08502
Correspondent Contact DONALD C EPSTEIN
Regulation Number870.5300
Classification Product Code
LDD  
Date Received07/14/1987
Decision Date 10/09/1987
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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