REPLACEMENT BATTERIES FOR MEDICAL INSTRUMENTATION

Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

ENERGY CONCEPTS, INC.

The following data is part of a premarket notification filed by Energy Concepts, Inc. with the FDA for Replacement Batteries For Medical Instrumentation.

Pre-market Notification Details

Device IDK872476
510k NumberK872476
Device Name:REPLACEMENT BATTERIES FOR MEDICAL INSTRUMENTATION
ClassificationMonitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Applicant ENERGY CONCEPTS, INC. P.O. BOX 128 5205 D AVENIDA ENCINAS Carlsbad,  CA  92008
ContactDonald S Diehl
CorrespondentDonald S Diehl
ENERGY CONCEPTS, INC. P.O. BOX 128 5205 D AVENIDA ENCINAS Carlsbad,  CA  92008
Product CodeMHX  
Subsequent Product CodeDQI
Subsequent Product CodeLDD
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-06-23
Decision Date1987-09-21

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