Ics Medical Vemr Video Eye Movement Recorder

Q: What is the product code of K972631?

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

FDA 510(k) K972631 · Ics Medical Corp.

Substantially Equivalent

510(k) numberK972631

Submission

Device name: Ics Medical Vemr Video Eye Movement Recorder
Applicant: Ics Medical Corp.
Schaumburg, IL, US
Received: July 14, 1997
Decision date: September 22, 1997
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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Questions and answers

When was Ics Medical Vemr Video Eye Movement Recorder cleared by the FDA?

Ics Medical Vemr Video Eye Movement Recorder (K972631) received a 510(k) decision of Substantially Equivalent on September 22, 1997, 70 days after the submission was received.

What is the product code of K972631?

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