Emg System

FDA 510(k) K111687 · Myotronics-Noromed, Inc.

Substantially Equivalent

510(k) numberK111687

Submission

Device name
Emg System
Applicant
Myotronics-Noromed, Inc.
Kent, WA, US
Received
June 16, 2011
Decision date
September 29, 2011
Decision
Substantially Equivalent (SESE)
Type
Special 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 Emg System cleared by the FDA?

Emg System (K111687) received a 510(k) decision of Substantially Equivalent on September 29, 2011, 105 days after the submission was received.

What is the product code of K111687?

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