Neurotrek Physiological Navigation System for Neurosurgery

Q: What is the product code of K993622?

The FDA product code is GZL – Electrode, Depth, a Class II (moderate risk) device regulated under 21 CFR 882.1330.

FDA 510(k) K993622 · Alpha Omega , Ltd.

Substantially Equivalent

510(k) numberK993622

Submission

Device name: Neurotrek Physiological Navigation System for Neurosurgery
Applicant: Alpha Omega , Ltd.
Ra'Ananna 43373, IL
Received: October 26, 1999
Decision date: January 24, 2000
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: GZL – Electrode, Depth
Device class: Class II (moderate risk)
Regulation: 21 CFR 882.1330
Specialty: Neurology

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Questions and answers

When was Neurotrek Physiological Navigation System for Neurosurgery cleared by the FDA?

Neurotrek Physiological Navigation System for Neurosurgery (K993622) received a 510(k) decision of Substantially Equivalent on January 24, 2000, 90 days after the submission was received.

What is the product code of K993622?

The FDA product code is GZL – Electrode, Depth, a Class II (moderate risk) device regulated under 21 CFR 882.1330.