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U.S. Department of Health and Human Services

Product Classification

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Device electromyograph, diagnostic
Regulation Description Diagnostic electromyograph.
Regulation Medical Specialty Physical Medicine
Review Panel Neurology
Product CodeIKN
Premarket Review Office of Device Evaluation (ODE)
Division of Neurological and Physical Medicine Devices (DNPMD)
Neurodiagnostic and Neurosurgical Devices Branch (NNDB)
Submission Type 510(k)
Regulation Number 890.1375
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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