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U.S. Department of Health and Human Services

Product Classification

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Device nebulizer (direct patient interface)
Regulation Description Nebulizer.
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodeCAF
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 868.5630
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators
Third Party Review
Accredited Persons

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