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U.S. Department of Health and Human Services

Product Classification

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Device device, electroconvulsive therapy
Regulation Description Electroconvulsive therapy device.
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeGXC
Premarket Review Office of Device Evaluation (ODE)
Division of Neurological and Physical Medicine Devices (DNPMD)
Neurostimulation Devices Branch (NSDB)
Submission Type 510(k)
Regulation Number 882.5940
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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