Myosystem 1000 Electromyograph

FDA 510(k) K895635 · Noraxon USA, Inc.

Substantially Equivalent

510(k) numberK895635

Submission

Device name
Myosystem 1000 Electromyograph
Applicant
Noraxon USA, Inc.
Scottsdale, AZ, US
Received
September 19, 1989
Decision date
April 19, 1990
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HCC – Device, Biofeedback
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5050
Specialty
Neurology

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Questions and answers

When was Myosystem 1000 Electromyograph cleared by the FDA?

Myosystem 1000 Electromyograph (K895635) received a 510(k) decision of Substantially Equivalent on April 19, 1990, 212 days after the submission was received.

What is the product code of K895635?

The FDA product code is HCC – Device, Biofeedback, a Class II (moderate risk) device regulated under 21 CFR 882.5050.