Eyetracker/Ideas

FDA 510(k) K070670 · S.A. Instrumentation Difra

Substantially Equivalent

510(k) numberK070670

Submission

Device name
Eyetracker/Ideas
Applicant
S.A. Instrumentation Difra
Cheyenne, WY, US
Received
March 12, 2007
Decision date
September 18, 2007
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GWN – Nystagmograph
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1460
Specialty
Neurology

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K200534VisualEyesGWN · Traditional Interacoustics A/S08/12/2020SE
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Questions and answers

When was Eyetracker/Ideas cleared by the FDA?

Eyetracker/Ideas (K070670) received a 510(k) decision of Substantially Equivalent on September 18, 2007, 190 days after the submission was received.

What is the product code of K070670?

The FDA product code is GWN – Nystagmograph, a Class II (moderate risk) device regulated under 21 CFR 882.1460.