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U.S. Department of Health and Human Services

Product Classification

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Device brain temperature measurement system
Definition A brain temperature measurement system is an externally placed, prescription device intended to measure brain temperature.
Physical State A sensor placed on the skin surface is used to measure brain temperature. Device includes software processing to convert the raw signal into a temperature measurement for display by the device or a compatible vital signs monitor.
Technical Method Measures brain temperature below the externally placed sensor.
Target Area Device is used on the head to measure brain temperature.
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeQSL
Premarket Review Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
Submission Type 510(k)
Regulation Number 882.1565
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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