CA2000

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

510(k) Number

K842611 ↗

FDA Product Code

IKN

Device Class

Class II

Regulation

21 CFR Part 890.1375

Advisory Committee

Physical Medicine

FDA Decision

SESE Substantially Equivalent

• EMG Surface, Digital Ring, Bar, Grounding, EEG

  Class II

  FDA 510(k) K850108 Active Cleared 11 Apr 1985

• Nicolet Viking

  Class II

  FDA 510(k) K842956 Active Cleared 3 Aug 1984

• Nic-200 Ventricular Function Analyzer

  Class I

  FDA 510(k) K792466 Active Cleared 24 Jan 1980

• Arteoial Tonometer Ml-105

  Class II

  FDA 510(k) K771449 Active Cleared 6 Sep 1977

• Compact Visual

  Class II

  FDA 510(k) K842613 Active Cleared 20 Jul 1984

• Brain Function Mapping Option for Pathf

  Class II

  FDA 510(k) K843598 Active Cleared 11 Apr 1985

See all devices from Nicolet Biomedical Instruments →

• What is the CA2000 device used for?

  The CA2000 is an electromyograph diagnostic device used to measure and record the electrical activity of muscles for diagnostic purposes in physical medicine.

• How is the CA2000 supplied and what are its regulatory details?

  The CA2000 is supplied by Nicolet Biomedical Instruments and has been cleared by the FDA with authorization number K842611, classified as a Class 2 device under regulation number 890.1375.

• What is the intended use and classification of the CA2000?

  The CA2000 is classified as a Physical Medicine device with product code IKN, intended for diagnostic purposes in physical medicine to provide information on muscle electrical activity.

• Is the CA2000 a single-use or reusable device?

  The device data does not specify whether the CA2000 is designed for single-use or multiple uses, as this information is not provided in the regulatory documentation.