Arbo Vs Monitor Cable & Leadwire System Arbo Shielded Safety Cable & Lead Wire

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

510(k) Number

K940322 ↗

FDA Product Code

DSA

Device Class

Class II

Regulation

21 CFR Part 870.2900

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Arbo Monitring Safety Cable & Lead Wire Systems/Arbo Unsheilded Safety Cable & Lead System

  Class II

  FDA 510(k) K940302 Active Cleared 30 Nov 1994

• Arbo H85V/H87V/H27V Dispos Monit Electrodes

  Class II

  FDA 510(k) K935437 Active Cleared 6 Apr 1995

• Arbo Diagnostic ECG Patient Cables & Leadwires Arbo Shielded Multi-Lead Cable & Lead System

  Class II

  FDA 510(k) K940323 Active Cleared 12 Apr 1995

• Arbo H90, H91, H135 Disposable Monitoring Electrodes

  Class II

  FDA 510(k) K935429 Active Cleared 1 Nov 1994

• Arbo H79P Disposable Monitoring Electrodes

  Class II

  FDA 510(k) K894562 Active Cleared 5 Sep 1989

• Pressure Tubing and Accessories

  Class II

  FDA 510(k) K901816 Active Cleared 12 Jul 1990

See all devices from Arbo Medical, Inc. →

• What is the Arbo VS Monitor Cable & Leadwire System used for?

  The Arbo VS Monitor Cable & Leadwire System is designed for cardiovascular monitoring. It connects vital sign monitors to patients, transmitting accurate electrocardiogram (ECG) signals and other physiological data while minimizing electrical interference. This ensures reliable monitoring in clinical settings, such as hospitals and cardiac care units.

• How is the Arbo Shielded VS Monitor Cable System supplied?

  The system is supplied as a complete cable and leadwire assembly, combining a shielded safety cable with lead wires. It is manufactured by Arbo Medical, Inc., and comes pre-packaged for immediate clinical use. The shielding helps reduce electromagnetic interference, which is critical for maintaining signal clarity during patient monitoring.

• Is the Arbo VS Monitor Cable & Leadwire System single-use or reusable?

  The device data does not specify single-use or reusable status explicitly. However, shielded safety cables and leadwire systems in this category are typically designed for single-use in clinical settings to ensure patient safety, sterility, and compliance with infection control protocols. Always verify with the manufacturer or facility policies before reuse.

• What regulatory approval does the Arbo VS Monitor Cable System hold?

  The Arbo VS Monitor Cable & Leadwire System holds FDA 510(k) clearance under the classification of *Cable, Transducer And Electrode, Patient (Including Connector)* with the product code DSA and regulation number 870.2900. The clearance was granted in 1994, and the device was deemed *Substantially Equivalent* to a predicate device by the FDA’s Cardiovascular Advisory Committee.

• How should the Arbo Shielded VS Monitor Cable System be stored?

  While specific storage instructions are not detailed in the provided data, shielded medical cables like this one should generally be stored in a clean, dry environment away from direct sunlight, extreme temperatures, or sources of electromagnetic interference. Ensure the packaging remains intact to protect the cable from physical damage or contamination before use. Always follow the manufacturer’s guidelines for optimal performance and longevity.