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FDA 510(k)

EYE TRAK TM, COMPUTERIZED ELECTRONYSTAGMOGRAPH (ENG), MODEL ETV-XXXX

K-Number: K991642 · 1999-08-03

ApplicantBertec Corp.
Decision Date1999-08-03
Product CodeGWN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EYE TRAK TM, COMPUTERIZED ELECTRONYSTAGMOGRAPH (ENG), MODEL ETV-XXXX is the device name listed in this FDA 510(k) record. The listed applicant is Bertec Corp.. It received FDA 510(k) clearance on 1999-08-03 under 510(k) number K991642. The device is classified under product code GWN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EYE TRAK TM, COMPUTERIZED ELECTRONYSTAGMOGRAPH (ENG), MODEL ETV-XXXX?

EYE TRAK TM, COMPUTERIZED ELECTRONYSTAGMOGRAPH (ENG), MODEL ETV-XXXX is a medical device that received FDA 510(k) clearance on 1999-08-03. The listed applicant is Bertec Corp.. The 510(k) number is K991642.

When did EYE TRAK TM, COMPUTERIZED ELECTRONYSTAGMOGRAPH (ENG), MODEL ETV-XXXX receive FDA 510(k) clearance?

EYE TRAK TM, COMPUTERIZED ELECTRONYSTAGMOGRAPH (ENG), MODEL ETV-XXXX received FDA 510(k) clearance on 1999-08-03, under 510(k) number K991642.

Who is the listed applicant for EYE TRAK TM, COMPUTERIZED ELECTRONYSTAGMOGRAPH (ENG), MODEL ETV-XXXX?

The FDA 510(k) record lists Bertec Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EYE TRAK TM, COMPUTERIZED ELECTRONYSTAGMOGRAPH (ENG), MODEL ETV-XXXX?

The FDA product code for EYE TRAK TM, COMPUTERIZED ELECTRONYSTAGMOGRAPH (ENG), MODEL ETV-XXXX is GWN.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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