Metraco Evoked Potential System

FDA 510(k) K821250 · Metraco, Inc.

Substantially Equivalent

510(k) numberK821250

Submission

Device name
Metraco Evoked Potential System
Applicant
Metraco, Inc.
Mchenry, IL, US
Received
April 30, 1982
Decision date
July 2, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GWL – Amplifier, Physiological Signal
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1835
Specialty
Neurology

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Questions and answers

When was Metraco Evoked Potential System cleared by the FDA?

Metraco Evoked Potential System (K821250) received a 510(k) decision of Substantially Equivalent on July 2, 1982, 63 days after the submission was received.

What is the product code of K821250?

The FDA product code is GWL – Amplifier, Physiological Signal, a Class II (moderate risk) device regulated under 21 CFR 882.1835.