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U.S. Department of Health and Human Services

Product Classification

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Device device, monitoring, intracranial pressure
Regulation Description Intracranial pressure monitoring device.
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeGWM
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 882.1620
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Third Party Review
Accredited Persons

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