Device |
analyzer, gas, sevoflurane, gaseous-phase (anesthetic concentration) |
Regulation Description |
Enflurane gas analyzer. |
Definition |
A sevoflurane gas analyzer is a device intended to measure the concentration of sevoflurane anesthetic in a gas mixture |
Regulation Medical Specialty |
Anesthesiology |
Review Panel |
Anesthesiology |
Product Code | NHP |
Premarket Review |
Division of Anesthesia, Respiratory, and Sleep Devices
(DHT1C)
Division of Anesthesia, Respiratory, and Sleep Devices
(DHT1C)
|
Submission Type |
510(k)
|
Regulation Number |
868.1500
|
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? |
No
|
Recognized Consensus Standard
|
Third Party Review
|
Accredited Persons
|