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Bard Biopotential Amplifier

FDA 510(k)

Class II (US FDA 510(k))

510(k) K874441

by C. R. Bard, Inc.

Identifiers

510(k) Number
K874441 FDA 510(k)
FDA Product Code
DRR FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.2050 FDA 510(k)
Regulation Number
870.2050 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Bard Biopotential Amplifier is an Amplifier and Signal Conditioner, Biopotential, designed to amplify and process weak electrical signals from biopotential sources such as electrocardiograms (ECGs) or electromyograms (EMGs). It enhances signal clarity for accurate monitoring and diagnostic assessment in cardiovascular applications, ensuring reliable amplification of physiological signals for clinical use.

This device is intended for use in clinical settings, supplied as a reusable medical instrument under FDA 510(k) clearance (K874441). It adheres to Class II regulatory standards with special controls and is classified under product code DRR. No sterility or single-use specifications are noted; it requires proper calibration and maintenance in accordance with manufacturer guidelines.

Frequently asked questions

What clinical applications is the Bard Biopotential Amplifier primarily designed for, and how does it improve signal accuracy in those settings?

The Bard Biopotential Amplifier is designed to amplify and process weak electrical signals from biopotential sources like electrocardiograms (ECGs) and electromyograms (EMGs), making it ideal for cardiovascular monitoring and diagnostic assessments. It enhances signal clarity by improving the strength and reliability of physiological signals, which helps clinicians achieve more accurate readings during patient evaluations.

Is the Bard Biopotential Amplifier intended for single-use or reusable clinical settings, and what maintenance is required?

The Bard Biopotential Amplifier is supplied as a reusable medical instrument, meaning it is meant for repeated use in clinical settings. Since it is not sterile or single-use, proper calibration and maintenance are essential to ensure consistent performance, as outlined in the manufacturer’s guidelines.

What regulatory pathway was followed for FDA clearance of this device, and what class does it fall under?

The Bard Biopotential Amplifier received FDA clearance through a 510(k) premarket notification process, specifically under Traditional Review with a Substantially Equivalent (SESE) determination. It is classified as a Class II medical device under the Cardiovascular advisory committee (CV) and falls under product code DRR, indicating it is subject to special controls.

How does the device’s signal conditioning benefit ECG and EMG monitoring compared to standard amplifiers?

The Bard Biopotential Amplifier is specifically engineered to amplify and condition weak biopotential signals, reducing noise interference and distortion that can occur in ECG and EMG readings. This ensures clearer, more precise physiological data, which is critical for accurate cardiovascular diagnostics and patient assessment in clinical environments.

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: BARD BIOPOTENTIAL AMPLIFIER II (K901358) — FDA 510 (k) | Innolitics, BARD BIOPOTENTIAL AMPLIFIER II (K901358) - FDA 510 (k), BARD BIOPOTENTIAL… — K901358 · DeviceClearance, K874441 FDA 510 (k) - BARD BIOPOTENTIAL AMPLIFIER

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
C. R. Bard, Inc.
FDA Applicant
C.R. Bard, Inc.

Sources (1)

  • FDA 510(k) K874441 24 fields · synced Sep 19, 2026