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U.S. Department of Health and Human Services

Product Classification
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Device software, transmission and storage, patient data
Definition Non-alarming software that captures patient data from patient monitoring devices and transmits the data to the patient electronic medical record, where the data is stored.
Review Panel General Hospital
Product CodeNSX
Premarket Review Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
Unclassified Reason Pre-Amendment
Submission Type Contact ODE
Device Class Unclassified
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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