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FDA 510(k)

CHRONOS VISION EYE TRACKING DEVICE (C-ETD)

K-Number: K062015 · 2006-10-31

ApplicantChronos Vision
Decision Date2006-10-31
Product CodeGWN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CHRONOS VISION EYE TRACKING DEVICE (C-ETD) is the device name listed in this FDA 510(k) record. The listed applicant is Chronos Vision. It received FDA 510(k) clearance on 2006-10-31 under 510(k) number K062015. 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 CHRONOS VISION EYE TRACKING DEVICE (C-ETD)?

CHRONOS VISION EYE TRACKING DEVICE (C-ETD) is a medical device that received FDA 510(k) clearance on 2006-10-31. The listed applicant is Chronos Vision. The 510(k) number is K062015.

When did CHRONOS VISION EYE TRACKING DEVICE (C-ETD) receive FDA 510(k) clearance?

CHRONOS VISION EYE TRACKING DEVICE (C-ETD) received FDA 510(k) clearance on 2006-10-31, under 510(k) number K062015.

Who is the listed applicant for CHRONOS VISION EYE TRACKING DEVICE (C-ETD)?

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

What is the FDA product code for CHRONOS VISION EYE TRACKING DEVICE (C-ETD)?

The FDA product code for CHRONOS VISION EYE TRACKING DEVICE (C-ETD) is GWN.

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Related Devices (Code: GWN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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