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U.S. Department of Health and Human Services

Product Classification

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Device spirometer, diagnostic
Regulation Description Diagnostic spirometer.
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodeBZG
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 868.1840
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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