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U.S. Department of Health and Human Services

Product Classification
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Device system, hypothermia, intravenous, cooling
Regulation Description Thermal regulating system.
Regulation Medical Specialty Cardiovascular
Review Panel Neurology
Product CodeNCX
Premarket Review Office of Neurological and Physical Medicine Devices (OHT5)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
Submission Type 510(k)
Regulation Number 870.5900
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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