Device |
pump, infusion, insulin |
Regulation Description |
Infusion pump. |
Regulation Medical Specialty |
General Hospital |
Review Panel |
Clinical Chemistry |
Product Code | LZG |
Premarket Review |
Office of In Vitro Diagnostics and Radiological Health
(OIR)
|
Submission Type |
510(k)
|
Regulation Number |
880.5725
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Recognized Consensus Standards
|
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |
|
|