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U.S. Department of Health and Human Services

Product Classification
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Device computer-assisted personalized sedation system
Definition Computer assisted system to administer a drug and control depth of sedation and provide monitoring and alarms for physiological vital signs and other parameters of sedation.
Physical State Computer controlled infusion pump, multi-parameter physiological monitoring, negative feedback control system algorithm.
Technical Method Computer assisted drug administration using feedback from patient physiological parameters.
Target Area Central nervous system, cardiopulmonary system.
Review Panel Anesthesiology
Product CodePDR
Premarket Review Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
Submission Type PMA
Device Class 3
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 Not Third Party Eligible
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