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U.S. Department of Health and Human Services

Product Classification
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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 CodeQEM
Premarket Review Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
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
Third Party Review Not Third Party Eligible
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