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Cardiofax CE Model PEA-1110K

FDA 510(k)

Class II (US FDA 510(k))

510(k) K042827

by Nihon Kohden America, Inc.

Identifiers

510(k) Number
K042827 FDA 510(k)
FDA Product Code
DPS FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.2340 FDA 510(k)
Regulation Number
870.2340 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Cardiofax CE Model PEA-1110K is an electrocardiograph (ECG) device, classified under 21 CFR 870.2340, designed to acquire and record 12-lead ECG waveforms. It functions as a portable acquisition terminal, capturing electrical activity of the heart for diagnostic evaluation. This device aids clinicians in assessing cardiac rhythm, identifying arrhythmias, and diagnosing coronary artery disease or other cardiac conditions. Its primary role is in cardiovascular diagnostics, providing real-time or stored ECG data for clinical interpretation.

The Cardiofax CE Model PEA-1110K is supplied as a reusable medical device intended for use in clinical, hospital, or ambulatory settings. It requires proper calibration and maintenance to ensure accurate ECG readings. The device is not sterile and is not intended for single-use applications. No specific MRI safety information is provided, but its use must comply with standard electromagnetic interference guidelines. Authorized for commercial distribution in the United States under FDA 510(k) clearance (K042827), it adheres to regulatory standards for electrocardiographic devices.

Frequently asked questions

What is the Cardiofax CE Model PEA-1110K used for?

The Cardiofax CE Model PEA-1110K is an electrocardiograph (ECG) device designed to acquire and record 12-lead ECG waveforms. It captures the electrical activity of the heart to help clinicians assess cardiac rhythm, identify arrhythmias, and diagnose conditions such as coronary artery disease. The device provides real-time or stored ECG data for clinical interpretation, making it essential for cardiovascular diagnostics in hospital, clinical, or ambulatory settings.

Is the Cardiofax CE PEA-1110K a single-use or reusable device?

The Cardiofax CE PEA-1110K is a reusable medical device. It is not intended for single-use applications and requires proper calibration and maintenance to ensure accurate and reliable ECG readings over repeated use. Reusability is typical for devices used in clinical settings where durability and consistent performance are critical.

What settings is the Cardiofax CE PEA-1110K intended for?

This device is intended for use in clinical, hospital, or ambulatory settings. Its portability as an acquisition terminal makes it suitable for environments where ECG monitoring is required, such as emergency rooms, cardiac units, or outpatient clinics. The device is designed to support diagnostic evaluations in these controlled settings.

Does the Cardiofax CE PEA-1110K come sterile?

No, the Cardiofax CE PEA-1110K is not supplied sterile. It is a reusable device, and sterility is not applicable to its hardware components. However, proper cleaning and maintenance protocols must be followed to ensure hygiene and prevent contamination between uses.

What regulatory clearance does the Cardiofax CE PEA-1110K hold?

The Cardiofax CE PEA-1110K is authorized for commercial distribution in the United States under FDA 510(k) clearance with the clearance number K042827. This clearance indicates that the device has been determined to be substantially equivalent to a legally marketed predicate device, adhering to regulatory standards for electrocardiographic devices.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: CARDIOFAX CE, MODEL PEA-1110K (K042827) — FDA 510(k) | Innolitics, fda.innolitics.com, Nihon Kohden America Cardiofax Ce, Pea-1110K - allmed.wiki

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Nihon Kohden America, Inc.

Sources (1)

  • FDA 510(k) K042827 24 fields · synced Oct 1, 2026