Mega Me 3000 Professional Muscle Tester

FDA 510(k) K963202 · Mega Electronics , Ltd.

Substantially Equivalent

510(k) numberK963202

Submission

Device name
Mega Me 3000 Professional Muscle Tester
Applicant
Mega Electronics , Ltd.
Eagan, MN, US
Received
August 15, 1996
Decision date
May 19, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

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 Mega Me 3000 Professional Muscle Tester cleared by the FDA?

Mega Me 3000 Professional Muscle Tester (K963202) received a 510(k) decision of Substantially Equivalent on May 19, 1997, 277 days after the submission was received.

What is the product code of K963202?

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