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THE BETA

by Burdick Corp. 510(k)

Active United States

510(k) K810940

Overview

THE BETA is a Class 2 arrhythmia detector and alarm manufactured by Burdick Corp. It is classified under product code DSI for cardiovascular diagnostic devices. The device functions as an arrhythmia detector and alarm, designed to monitor and alert to cardiac arrhythmias.

The device received FDA 510(k) clearance under the Traditional pathway with a substantially equivalent decision on July 16, 1981. It is regulated under regulation number 870.1025 and is associated with multiple registration numbers in the United States. The device is manufactured in Mchenry, IL, and is intended for use in cardiovascular settings.

AI-generated from registry data, 24 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK810940 Date16 Jul 1981ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DSI
Device Class
Class II
Regulation
21 CFR Part 870.1025
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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