MA-300 Electromyography System

FDA 510(k) K000220 · Motion Lab Systems, Inc.

Substantially Equivalent

510(k) numberK000220

Submission

Device name
MA-300 Electromyography System
Applicant
Motion Lab Systems, Inc.
Baton Rouge, LA, US
Received
January 24, 2000
Decision date
February 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
IKN – Electromyograph, Diagnostic
Device class
Class II (moderate risk)
Regulation
21 CFR 890.1375
Specialty
Physical Medicine

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Questions and answers

When was MA-300 Electromyography System cleared by the FDA?

MA-300 Electromyography System (K000220) received a 510(k) decision of Substantially Equivalent on February 24, 2000, 31 days after the submission was received.

What is the product code of K000220?

The FDA product code is IKN – Electromyograph, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 890.1375.