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U.S. Department of Health and Human Services

Product Classification

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Device meter, peak flow, spirometry
Regulation Description Peak-flow meter for spirometry.
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodeBZH
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 868.1860
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Guidance Document
  • Guidance for Peak Flow Meters for Over-the-Counter Sale [http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM081354.pdf] 
Third Party Review
Accredited Persons

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