Device |
analyzer, gas, neon, gaseous-phase |
Regulation Description |
Neon gas analyzer. |
Regulation Medical Specialty |
Anesthesiology |
Review Panel |
Anesthesiology |
Product Code | JEF |
Premarket Review |
Division of Anesthesia, Respiratory, and Sleep Devices
(DHT1C)
Division of Anesthesia, Respiratory, and Sleep Devices
(DHT1C)
|
Submission Type |
510(k)
|
Regulation Number |
868.1670
|
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
|
Third Party Review
|
Accredited Persons
|
|
|