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U.S. Department of Health and Human Services

Product Classification

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Device amplifier, physiological signal
Regulation Description Physiological signal amplifier.
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeGWL
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 882.1835
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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