Model 4000 Evoked Potential Measurement System

Q: What is the product code of K894608?

The FDA product code is GWF – Stimulator, Electrical, Evoked Response, a Class II (moderate risk) device regulated under 21 CFR 882.1870.

FDA 510(k) K894608 · Micro-Shev , Ltd.

Substantially Equivalent

510(k) numberK894608

Submission

Device name: Model 4000 Evoked Potential Measurement System
Applicant: Micro-Shev , Ltd.
Efrat, IL
Received: July 18, 1989
Decision date: December 29, 1989
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code: GWF – Stimulator, Electrical, Evoked Response
Device class: Class II (moderate risk)
Regulation: 21 CFR 882.1870
Specialty: Neurology

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More from Alphatec Spine, Inc.

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K874193	Microshev Model 2000GWJ · Traditional	03/21/1988SE
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Questions and answers

When was Model 4000 Evoked Potential Measurement System cleared by the FDA?

Model 4000 Evoked Potential Measurement System (K894608) received a 510(k) decision of Substantially Equivalent on December 29, 1989, 164 days after the submission was received.

What is the product code of K894608?

The FDA product code is GWF – Stimulator, Electrical, Evoked Response, a Class II (moderate risk) device regulated under 21 CFR 882.1870.