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U.S. Department of Health and Human Services

Product Classification

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Device monitor, lesion temperature
Regulation Description Lesion temperature monitor.
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeGXT
Premarket Review Neurological and Physical Medicine Devices (OHT5)
Neurosurgical, Neurointerventional and Neurodiagnostics (DHT5A)
Submission Type 510(k)
Regulation Number 882.5500
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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