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 ID: K103706
• 510k Number: K103706
• Device Name: THE CORE (CARDIAC OUTPATIENT REALTIME ECG) MONITOR
• Classification: Detector And Alarm, Arrhythmia
• Applicant: APPLIED CARDIAC SYSTEMS, INC. 22912 El Pacifico Dr Laguna Hills, CA 92653
• Contact: R. Ben Ghadimi
• Correspondent: R. Ben Ghadimi; APPLIED CARDIAC SYSTEMS, INC. 22912 El Pacifico Dr Laguna Hills, CA 92653
• Product Code: DSI
• CFR Regulation Number: 870.1025 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-12-20
• Decision Date: 2011-08-24
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00853512007001	K103706	000