Arrhythmia III Cardule #1919

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

510(k) Number

K832693 ↗

FDA Product Code

DSI

Device Class

Class II

Regulation

21 CFR Part 870.1025

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Heartrate Plus ECG Cardule #1918

  Class II

  FDA 510(k) K830306 Active Cleared 17 Mar 1983

• Spacelabs Series 1000

  Class II

  FDA 510(k) K760612 Active Cleared 21 Sep 1976

• Spacelabs Series 90700 Patient Monitors

  Class II

  FDA 510(k) K862951 Active Cleared 23 Sep 1986

• Spacelabs-General System Link

  Class II

  FDA 510(k) K850627 Active Cleared 28 May 1985

• Spacelabs Arrhythmia Net (Tm) Level 2

  Class II

  FDA 510(k) K864505 Active Cleared 24 Nov 1986

• Space Labs Model 90560

  Not classified

  FDA 510(k) K923788 Active Cleared 6 Dec 1993

See all devices from Spacelabs, Inc. →

• What is the Arrhythmia III Cardule #1919 used for?

  The Arrhythmia III Cardule #1919 is a detector and alarm device designed specifically to identify and signal cardiac arrhythmias. It aids healthcare providers in monitoring patients for abnormal heart rhythms, enabling early detection of potential cardiac events. This is particularly useful in clinical settings like intensive care units (ICU) or cardiac care units where continuous cardiac monitoring is critical.

• Is the Arrhythmia III Cardule #1919 a single-use or reusable device?

  The Arrhythmia III Cardule #1919 is a reusable medical instrument. This classification allows for repeated use after proper cleaning, disinfection, and maintenance, making it cost-effective for clinical environments where continuous cardiac monitoring is required.

• What regulatory approval does the Arrhythmia III Cardule #1919 hold?

  The Arrhythmia III Cardule #1919 holds FDA 510(k) clearance under the product code DSI, with a clearance number of K832693. This approval confirms that the device meets regulatory standards for cardiovascular diagnostics and is authorized for distribution in the United States.

• In which clinical settings is the Arrhythmia III Cardule #1919 intended for use?

  This device is intended for use in clinical settings where continuous cardiac monitoring is essential, such as intensive care units (ICU) and cardiac care units. Its primary purpose is to provide real-time detection and alerting of abnormal heart rhythms, helping healthcare providers respond promptly to potential cardiac events.

• What is the classification of the Arrhythmia III Cardule #1919 under FDA regulations?

  The Arrhythmia III Cardule #1919 is classified as a Class II medical device under FDA regulations. This classification indicates that it poses moderate risk and requires special controls to ensure its safety and effectiveness, including the FDA 510(k) clearance process.