THE CORE (CARDIAC OUTPATIENT REALTIME ECG) MONITOR

Detector And Alarm, Arrhythmia

APPLIED CARDIAC SYSTEMS, INC.

The following data is part of a premarket notification filed by Applied Cardiac Systems, Inc. with the FDA for The Core (cardiac Outpatient Realtime Ecg) Monitor.

Pre-market Notification Details

Device IDK103706
510k NumberK103706
Device Name:THE CORE (CARDIAC OUTPATIENT REALTIME ECG) MONITOR
ClassificationDetector And Alarm, Arrhythmia
Applicant APPLIED CARDIAC SYSTEMS, INC. 22912 El Pacifico Dr Laguna Hills,  CA  92653
ContactR. Ben Ghadimi
CorrespondentR. Ben Ghadimi
APPLIED CARDIAC SYSTEMS, INC. 22912 El Pacifico Dr Laguna Hills,  CA  92653
Product CodeDSI  
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-12-20
Decision Date2011-08-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00853512007001 K103706 000

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