Product Classification

• Device: cerebral oximeter
• Regulation Description: Oximeter.
• Definition: Oximeter to measure cerebral tissue saturation
• Physical State: Light radiation transmitter and receiver with associated analytical hardware and software to process the signal
• Technical Method: Transmits light radiation at known wavelength(s) through blood to measure oxygen saturation based on the amount of reflected or scattered radiation
• Target Area: Head, Skull, Brain
• Regulation Medical Specialty: Cardiovascular
• Review Panel: Neurology
• Product Code: QEM
• Premarket Review: Office of Neurological and Physical Medicine Devices (OHT5); Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
• Submission Type: 510(k)
• Regulation Number: 870.2700
• 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 Standard

• 17-19 ISO 80601-2-85 Edition 1.0 2021-03
  Medical electrical equipment - Part 2-85: Particular requirements for the basic safety and essential performance of cerebral tissue oximeter equipment

Third Party Review

Not Third Party Eligible