C-ERA-100 Computerized Electric Response Stimulator

No FDA recalls on record, checked 22 Oct 2026.

Full name

C-Era-100 Computerized Electric Respon

510(k) Number

K792085 ↗

FDA Product Code

GWJ

FDA applicant

Micro-Shev , Ltd.

Device Class

Class II

Regulation

21 CFR Part 882.1900

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• Model 4000 Evoked Potential Measurement System

  Class II

  FDA 510(k) K894608 Active Cleared 29 Dec 1989

• 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

• What is the C-Era-100 used for in clinical settings?

  The C-Era-100 is an Auditory Evoked Response Stimulator designed to deliver controlled auditory signals for assessing auditory function. It measures brainstem and cortical responses to diagnose hearing disorders, evaluate auditory pathway integrity, and aid in the assessment of neurological conditions. This objective testing helps clinicians identify issues like hearing loss or auditory processing disorders without relying solely on subjective patient reports.

• Is the C-Era-100 a single-use or reusable device?

  The C-Era-100 is supplied as a reusable medical instrument. Since it is intended for clinical use in environments like neurology departments, proper calibration and maintenance are required to ensure accurate and reliable performance over multiple uses. Reusability reduces waste but necessitates adherence to manufacturer guidelines for cleaning, sterilization (if applicable), and routine servicing.

• Does the C-Era-100 require any special storage conditions?

  The provided data does not specify special storage conditions for the C-Era-100, but as a reusable Class II device, it should be stored in a clean, dry environment protected from physical damage, extreme temperatures, and humidity. Follow the manufacturer’s instructions for long-term storage, especially if the device is not in regular use, to preserve its functionality and calibration accuracy.

• What regulatory approval does the C-Era-100 hold?

  The C-Era-100 holds FDA 510(k) clearance under the product code GWJ, with a clearance number of K792085. This classification under 21 CFR 882.1900 confirms it meets U.S. regulatory standards for safety and effectiveness as an Auditory Evoked Response Stimulator. The device was reviewed by the Neurology (NE) Advisory Committee and classified as substantially equivalent to a predicate device.

• Are there any specific sterility or MRI safety considerations for the C-Era-100?

  The available data does not provide explicit information regarding sterility requirements or MRI safety for the C-Era-100. Since it is a reusable device, sterility may not apply unless specific procedures (e.g., disinfection between patients) are mandated by the manufacturer or facility protocols. For MRI safety, clinicians should verify compatibility with their facility’s MRI systems, as electromagnetic interference or metal components could pose risks in magnetic environments.