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 Code | QLI |
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 |
|
|