Infrared Eye Movement Monitor

FDA 510(k) K926312 · Microguide, Inc.

Substantially Equivalent

510(k) numberK926312

Submission

Device name
Infrared Eye Movement Monitor
Applicant
Microguide, Inc.
Dolton, IL, US
Received
December 15, 1992
Decision date
December 15, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement 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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Questions and answers

When was Infrared Eye Movement Monitor cleared by the FDA?

Infrared Eye Movement Monitor (K926312) received a 510(k) decision of Substantially Equivalent on December 15, 1994, 730 days after the submission was received.

What is the product code of K926312?

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