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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 Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
Submission Type 510(k)
Regulation Number 882.1620
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review
Accredited Persons
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