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FDA 510(k)

EYETRACKER/IDEAS

K-Number: K070670 · 2007-09-18

ApplicantS.A. Instrumentation Difra
Decision Date2007-09-18
Product CodeGWN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EYETRACKER/IDEAS is the device name listed in this FDA 510(k) record. The listed applicant is S.A. Instrumentation Difra. It received FDA 510(k) clearance on 2007-09-18 under 510(k) number K070670. 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 EYETRACKER/IDEAS?

EYETRACKER/IDEAS is a medical device that received FDA 510(k) clearance on 2007-09-18. The listed applicant is S.A. Instrumentation Difra. The 510(k) number is K070670.

When did EYETRACKER/IDEAS receive FDA 510(k) clearance?

EYETRACKER/IDEAS received FDA 510(k) clearance on 2007-09-18, under 510(k) number K070670.

Who is the listed applicant for EYETRACKER/IDEAS?

The FDA 510(k) record lists S.A. Instrumentation Difra as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EYETRACKER/IDEAS?

The FDA product code for EYETRACKER/IDEAS 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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