VAT®

GUDID B435EV2000

WESTERN SYSTEMS RESEARCH INC.

Electronystagmograph
Primary Device IDB435EV2000
NIH Device Record Keyb7ea85b7-3e4d-45c9-a7b6-3822120c5fd5
Commercial Distribution StatusIn Commercial Distribution
Brand NameVAT®
Version Model NumberEV2000
Company DUNS608365466
Company NameWESTERN SYSTEMS RESEARCH INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB435EV2000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GWNNystagmograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-05-16

Devices Manufactured by WESTERN SYSTEMS RESEARCH INC.

B435ENGEV2000 - ENGplus™2023-08-17
B435MT07 - MotionTrak2023-07-05
B435OKN1 - Tracker2023-07-05
B435EV2000 - VAT®2018-07-06
B435EV2000 - VAT®2018-07-06

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