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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 Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
General Hospital Devices Branch (GHDB)
Not Classified Reason Enforcement Discretion
Submission Type Enforcement Discretion
Device Class Not Classified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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