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Cardiofax-V ECG-834OA

FDA 510(k)

Class II (US FDA 510(k))

510(k) K865032

by Nihon Kohden America, Inc.

Identifiers

510(k) Number
K865032 FDA 510(k)
FDA Product Code
DSI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1025 FDA 510(k)
Regulation Number
870.1025 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Cardiofax-V ECG-834OA is a Detector and Alarm, Arrhythmia device, designed to monitor and record electrocardiogram (ECG) waveforms. It detects cardiac arrhythmias and provides real-time ECG tracing for clinical assessment, supporting diagnostic evaluation in cardiovascular settings.

This device is intended for use in clinical environments, featuring memory storage for the most recent five minutes of 12-lead ECG waveforms. Supplied as a reusable medical instrument, it operates under FDA 510(k) clearance (K865032) and adheres to 21 CFR 870.1025 regulations. The device is not classified as single-use and lacks explicit MRI safety labeling in the provided data.

Frequently asked questions

Is the Cardiofax-V ECG-834OA designed for single-use or can it be reused in clinical settings?

The Cardiofax-V ECG-834OA is explicitly described as a reusable medical instrument. Since it is not labeled as single-use, it is intended for repeated use in clinical environments, provided it is properly cleaned, maintained, and serviced according to manufacturer guidelines.

What types of ECG recordings can the Cardiofax-V ECG-834OA store, and how long does it retain data?

The device is designed to monitor and record 12-lead ECG waveforms in real-time. It includes memory storage for the most recent five minutes of recordings, which supports diagnostic evaluation by allowing clinicians to review arrhythmias and cardiac activity over that timeframe.

Does the Cardiofax-V ECG-834OA have any specific regulatory approvals or pathways for use in the U.S.?

The device holds FDA 510(k) clearance (K865032) under the Traditional 510(k) Review pathway, with a decision classification of *Substantially Equivalent* to a predicate device. It adheres to 21 CFR 870.1025, which governs Detector and Alarm, Arrhythmia devices, and is filed under the Detector and Alarm (DSI) product code.

Can this device be used safely in areas with MRI equipment, or does it have any MRI-related restrictions?

The provided data does not include explicit MRI safety labeling for the Cardiofax-V ECG-834OA. This means its compatibility with MRI environments (e.g., proximity to magnetic fields) is not confirmed or documented in the available information, and caution should be exercised when using it near MRI systems.

What clinical environments or specialties is the Cardiofax-V ECG-834OA intended for, based on its design and regulatory classification?

The device is intended for clinical environments, particularly within cardiovascular settings, as indicated by its classification under the Cardiovascular medical specialty in regulatory filings. It is designed to assist in diagnostic evaluation of cardiac arrhythmias and real-time ECG monitoring, making it suitable for hospitals, clinics, and cardiac care units.

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-V ECG-834OA (K865032) - FDA 510 (k), CARDIOFAX-V ECG-834OA (K865032) — FDA 510 (k) | Innolitics, Cardiofax-v Ecg-834oa 510 (k) K865032 - FDA.report, CARDIOFAX-V ECG-834OA — K865032 · DeviceClearance, Nihon Kohden Cardiofax V with Interpretation

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) K865032 24 fields · synced Sep 19, 2026