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U.S. Department of Health and Human Services

Product Classification

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Device calculator, pulmonary function data
Regulation Description Pulmonary-function data calculator.
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodeBZC
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 868.1880
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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