NEUROMATIC 2000

K821237 · Disa Electronics · IKN · May 21, 1982 · Physical Medicine

Device Facts

Record IDK821237
Device NameNEUROMATIC 2000
ApplicantDisa Electronics
Product CodeIKN · Physical Medicine
Decision DateMay 21, 1982
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 890.1375
Device ClassClass 2

Regulatory Classification

Identification

A diagnostic electromyograph is a device intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor and display the electrical activity produced by nerves, for the diagnosis and prognosis of neuromuscular disease.

Innolitics
510(k) Summary
Decision Summary
Classification Order
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