Monopolar Emg Needle Electrode

Q: What is the product code of K933806?

The FDA product code is GXZ – Electrode, Needle, a Class II (moderate risk) device regulated under 21 CFR 882.1350.

FDA 510(k) K933806 · Cadwell Laboratories, Inc.

Substantially Equivalent

510(k) numberK933806

Submission

Device name: Monopolar Emg Needle Electrode
Applicant: Cadwell Laboratories, Inc.
Kennewick, WA, US
Received: August 4, 1993
Decision date: April 22, 1994
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: GXZ – Electrode, Needle
Device class: Class II (moderate risk)
Regulation: 21 CFR 882.1350
Specialty: Neurology

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K130220	MR Conditional Presson ElectrodeGXZ · Traditional	Rhythmlink International, LLC	07/22/2013SE

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Questions and answers

When was Monopolar Emg Needle Electrode cleared by the FDA?

Monopolar Emg Needle Electrode (K933806) received a 510(k) decision of Substantially Equivalent on April 22, 1994, 261 days after the submission was received.

What is the product code of K933806?

The FDA product code is GXZ – Electrode, Needle, a Class II (moderate risk) device regulated under 21 CFR 882.1350.