Device |
generator, oxygen, portable |
Regulation Description |
Portable oxygen generator. |
Regulation Medical Specialty |
Anesthesiology |
Review Panel |
Anesthesiology |
Product Code | CAW |
Premarket Review |
Office of Device Evaluation
(ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices
(DAGRID)
Anesthesiology Devices Branch (ANDB)
|
Submission Type |
510(k)
|
Regulation Number |
868.5440
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Recognized Consensus Standards
|
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review
|
Accredited Persons
|