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Applied Cardiac Systems, Inc.

US

Last updated May 31, 2026

What Applied Cardiac Systems, Inc. makes

Applied Cardiac Systems, Inc. manufactures telemetric electrocardiographic ambulatory recorders, including portable devices for continuous outpatient ECG monitoring such as the CORE12 and THE CORE (Cardiac Outpatient Realtime ECG) Monitor. These devices are designed to capture real-time cardiac data for diagnostic evaluation outside traditional clinical settings.

The company’s products fall under FDA Class II regulation and are listed via 510(k) premarket notifications and the FDA’s Unique Device Identifier (UDI) system. The manufacturer is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country
US
Address
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LinkedIn
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Facebook
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Phone
9499006144
PRRC Contact
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EUDAMED SRN
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FDA FEI Number
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DUNS Number
063186910

Catalogue (6)

DeviceModel / ReferenceRegistriesClassStatus
Core12 C18006
FDA UDI
Class IIActive
Acs Model Ncp-2 K042413
FDA 510(k)
Class IIActive
Holter Performer K813602
FDA 510(k)
Class IIActive
Holter Performer Feather Weight/Cass K833823
FDA 510(k)
Class IIActive
The Holter Reporter (tm) K860249
FDA 510(k)
Class IIActive
The Core (cardiac Outpatient Realtime Ecg) Monitor K103706
FDA 510(k)
Class IIActive

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