DG Examiner Plus

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

510(k) Number

K953799 ↗

FDA Product Code

OLT

FDA applicant

Medelec , Ltd.

Device Class

Class II

Regulation

21 CFR Part 882.1400

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

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See all devices from Medelec, Ltd. →

• What is the DG Examiner Plus used for?

  The DG Examiner Plus is a Non-Normalizing Quantitative Electroencephalograph Software designed to acquire, analyze, and interpret EEG signals. It quantifies brainwave activity to help clinicians assess neurological function and identify abnormalities such as epilepsy or sleep disorders in hospital or neurology clinic settings.

• How is the DG Examiner Plus supplied and does it require sterilization?

  The DG Examiner Plus is supplied as a software solution and operates on compatible hardware platforms. Since it is a software-only device, no sterilization is required. It is intended for use on existing EEG systems and does not involve disposable or reusable hardware components that would necessitate sterilization.

• Is the DG Examiner Plus single-use or reusable?

  The DG Examiner Plus is a reusable software solution. It is installed on compatible hardware platforms and can be used repeatedly across multiple EEG monitoring sessions. The software itself does not degrade with use, provided the underlying hardware meets manufacturer specifications.

• What regulatory approval does the DG Examiner Plus hold?

  The DG Examiner Plus holds FDA 510(k) clearance (K953799) under the substantial equivalence determination for neurology applications. It is classified as a Class II medical device and complies with FDA regulations for quantitative EEG analysis software.

• Are there different models or reference codes for the DG Examiner Plus?

  Yes, the DG Examiner Plus is supplied with multiple model and reference codes (e.g., 3004762958, 3002807739) for regulatory tracking and compliance. These codes correspond to different hardware configurations or software versions that maintain compatibility with the software’s intended use for quantitative EEG analysis.