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U.S. Department of Health and Human Services

Product Classification
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Device vaporizer, cder or cber led
Definition Vaporizers are products that vaporize and deliver drug substance to the site of action through inhalation route.
Physical State Vaporizers are products that vaporize and deliver drug substance to the site of action through inhalation route.
Technical Method Vaporizers are products that vaporize and deliver drug substance to the site of action through inhalation route.
Target Area Inhalation
Review Panel Anesthesiology
Product CodeQLI
Premarket Review Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
Not Classified Reason Unknown
Submission Type Contact ODE
Device Class Not Classified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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