Product Classification

• Device: device, monitoring, intracranial pressure
• Regulation Description: Intracranial pressure monitoring device.
• Regulation Medical Specialty: Neurology
• Review Panel: Neurology
• Product Code: GWM
• Premarket Review: Office of Neurological and Physical Medicine Devices (OHT5); 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

• 5-108 ISO 80369-6 First Edition 2016-03-15
  Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications.
• 17-1 AAMI NS28:1988/(R) 2015
  Intracranial pressure monitoring devices

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• beanstock consulting
• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc