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U.S. Department of Health and Human Services

Product Classification

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Device apparatus, nitric oxide delivery
Regulation Description Nitric oxide administration apparatus.
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodeMRN
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
Anesthesiology Devices Branch (ANDB)
Submission Type 510(k)
Regulation Number 868.5165
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Guidance Document for Premarket Notification Submissions for Nitric Oxide Delivery Apparatus, Nitric Oxide Analyzer and Nitrogen Dioxide Analyzer; Final
Third Party Review Not Third Party Eligible
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