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U.S. Department of Health and Human Services

Product Classification

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Device calculator, predicted values, pulmonary function
Regulation Description Predictive pulmonary-function value calculator.
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodeBTY
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
Respiratory Devices Branch (RPDB)
Submission Type 510(k)
Regulation Number 868.1890
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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