Product Classification

• Device: device, monitoring, intracranial pressure
• Regulation Description: Intracranial pressure monitoring device.
• Regulation Medical Specialty: Neurology
• Review Panel: Neurology
• Product Code: GWM
• 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

• AAMI NS28:1988/(R) 2010 Intracranial pressure monitoring devices

Third Party Review

• Eligible for Accredited Persons Expansion Pilot Program

Accredited Persons

• dekra certification b.v.
• intertek testing services
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.