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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
510(k) Number K872476
Device Name REPLACEMENT BATTERIES FOR MEDICAL INSTRUMENTATION
Applicant
Energy Concepts, Inc.
P.O. Box 128
5205 D Avenida Encinas
Carlsbad,  CA  92008
Applicant Contact DONALD S DIEHL
Correspondent
Energy Concepts, Inc.
P.O. Box 128
5205 D Avenida Encinas
Carlsbad,  CA  92008
Correspondent Contact DONALD S DIEHL
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Codes
DQI   LDD  
Date Received06/23/1987
Decision Date 09/21/1987
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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