ENGplus™

GUDID B435ENGEV2000

WESTERN SYSTEMS RESEARCH INC.

Electronystagmograph

• Primary Device ID: B435ENGEV2000
• NIH Device Record Key: 92dd21c6-9be1-443b-a959-6a6adada40a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENGplus™
• Version Model Number: EV2000
• Company DUNS: 608365466
• Company Name: WESTERN SYSTEMS RESEARCH INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B435ENGEV2000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K010059

FDA Product Code

• GWN: Nystagmograph

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-17
• Device Publish Date: 2023-08-09

Devices Manufactured by WESTERN SYSTEMS RESEARCH INC.

• B435ENGEV2000 - ENGplus™: 2023-08-17
• B435ENGEV2000 - ENGplus™: 2023-08-17
• B435MT07 - MotionTrak: 2023-07-05
• B435OKN1 - Tracker: 2023-07-05
• B435EV2000 - VAT®: 2018-07-06