Skip to content

BERS-400A Electrophysiological Amplifiers & Input

by Fisher Imaging Corp.

510(k) K853652

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 5 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 5 Oct 2026. What this means

Regulatory status

as of registry sync 5 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK853652 Date16 Jan 1986ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 5 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DRR
Device Class
Class II
Regulation
21 CFR Part 870.2050
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The BERS-400A is an Amplifier and Signal Conditioner, Biopotential, designed to amplify and process electrophysiological signals for cardiovascular applications. It functions as an input device for recording and analyzing biopotential signals, such as those generated during electrophysiological studies, ensuring accurate signal acquisition and conditioning for diagnostic purposes.

This device is supplied as a reusable medical instrument and is classified under FDA regulation 870.2050 as a Class II device. It is intended for use in clinical settings where electrophysiological monitoring is required, such as electrophysiology labs or cardiac catheterization suites. The BERS-400A holds an FDA 510(k) clearance (K853652) under the DRR product code, with a decision of Substantially Equivalent (SESE) following review by the Cardiovascular Advisory Committee in 1986.

Other devices from Fisher Imaging Corp.

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the BERS-400A used for in clinical settings?

    The BERS-400A is designed as an amplifier and signal conditioner for biopotential signals, specifically to amplify and process electrophysiological signals during cardiovascular applications. This includes recording and analyzing signals generated during electrophysiological studies, ensuring precise signal acquisition for diagnostic purposes in labs or cardiac catheterization suites.

  • Is the BERS-400A a reusable or single-use device?

    The BERS-400A is supplied as a reusable medical instrument. It is intended for repeated use in clinical environments where electrophysiological monitoring is required, such as electrophysiology labs or cardiac catheterization suites.

  • What regulatory classification does the BERS-400A hold?

    The BERS-400A is classified under FDA regulation 870.2050 as a Class II device. It received FDA 510(k) clearance (K853652) with a decision of Substantially Equivalent (SESE) following review by the Cardiovascular Advisory Committee in 1986.

  • What types of signals does the BERS-400A process?

    The BERS-400A is specialized for amplifying and conditioning biopotential signals, particularly those related to cardiovascular applications. This includes signals recorded during electrophysiological studies, such as those used in diagnosing cardiac conditions.

  • Where can the BERS-400A be used in a healthcare facility?

    The BERS-400A is intended for use in clinical settings where electrophysiological monitoring is essential, such as dedicated electrophysiology labs or cardiac catheterization suites. Its design ensures accurate signal processing for diagnostic cardiovascular evaluations.