EYE TRAK TM, COMPUTERIZED ELECTRONYSTAGMOGRAPH (ENG), MODEL ETV-XXXX— 510(k) K991642

Substantially Equivalent

Bertec Corp.

FDA 510(k) clearance K991642 for EYE TRAK TM, COMPUTERIZED ELECTRONYSTAGMOGRAPH (ENG), MODEL ETV-XXXX, Substantially Equivalent on 1999-08-03. Applicant: Bertec Corp.. Device class: 2.

Clearance details

Applicant: Bertec Corp.
Product code: Code GWN
Device class: Class 2
Regulation: 21 CFR 882.1460
Advisory panel: Neurology
Date received: 1999-05-13
Decision date: 1999-08-03
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Columbus, OH, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.