Eventmaster 2

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K820856 ↗

FDA Product Code

DSI

Device Class

Class II

Regulation

21 CFR Part 870.1025

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Cardiac Acquisition System, Icr 2001

  Class II

  FDA 510(k) K770705 Active Cleared 2 Jun 1977

• Scanner Trend System

  Class II

  FDA 510(k) K771374 Active Cleared 4 Aug 1977

• Holter Cardiography Sys 6201

  Class II

  FDA 510(k) K834397 Active Cleared 17 Apr 1984

• Series 4000 Stress & Exercise System

  Class II

  FDA 510(k) K801903 Active Cleared 11 Mar 1981

• Event Master Recorder

  Class II

  FDA 510(k) K812920 Active Cleared 2 Dec 1981

• Eventmaster 3 Holter Event Scanner

  Class I

  FDA 510(k) K821173 Active Cleared 18 May 1982

See all devices from Instruments For Cardiac Research →

• What is the Eventmaster 2 used for?

  The Eventmaster 2 is designed for cardiovascular monitoring and alarm functionality, specifically as a detector and alarm for arrhythmia, to alert clinicians to abnormal heart rhythms during patient monitoring.

• How was the Eventmaster 2 cleared for market?

  The Eventmaster 2 received FDA 510(k) clearance (K820856) on April 29, 1982, as substantially equivalent to a predicate device, meaning it met regulatory requirements through comparison to a legally marketed device.

• Who manufactures the Eventmaster 2 and what is its product code?

  The Eventmaster 2 is manufactured by Instruments For Cardiac Research and is assigned the product code DSI, which identifies the device type within the FDA’s classification system for regulatory tracking.