Model 4000 Evoked Potential Measurement System

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K894608 ↗

FDA Product Code

GWF

FDA applicant

Micro-Shev , Ltd.

Device Class

Class II

Regulation

21 CFR Part 882.1870

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• Microshev Model 2000

  Class II

  FDA 510(k) K874193 Active Cleared 21 Mar 1988

• EMG Option for Microshev 4000

  Class II

  FDA 510(k) K900378 Active Cleared 10 Apr 1990

• Coronet 100

  Class II

  FDA 510(k) K913785 Active Cleared 31 Dec 1991

• C-ERA-100 Computerized Electric Response Stimulator

  Class II

  FDA 510(k) K792085 Active Cleared 30 Oct 1979

• What is the Model 4000 Evoked Potential Measurement System used for?

  The Model 4000 Evoked Potential Measurement System is an electrical stimulator device used for evoked response measurements in neurology, specifically intended for neurological evoked potential testing as stated in its device description and authorization details.

• How is the Model 4000 Evoked Potential Measurement System supplied or configured for use?

  The device is supplied as a complete electrical stimulator system designed for evoked potential testing, with no indication of disposable components or single-use parts in the provided data; it is intended for repeated clinical use in neurology settings as a Class II medical device.

• Is the Model 4000 Evoked Potential Measurement System sterile or single-use?

  The device description does not indicate that the Model 4000 Evoked Potential Measurement System is sterile or single-use; as an electrical stimulator system for evoked potential testing, it is designed for reuse in clinical neurology environments following standard cleaning and maintenance procedures.