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U.S. Department of Health and Human Services

Product Classification

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Device apparatus, nitric oxide, backup delivery
Regulation Description Nitric oxide administration apparatus.
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodeMRO
Premarket Review Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
Submission Type 510(k)
Regulation Number 868.5165
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? Yes
Guidance Document
Third Party Review Not Third Party Eligible
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