Device Type ID | 2518 |
Device Name | Actuator, Syringe, Injector Type |
Regulation Description | Syringe Actuator For An Injector. |
Regulation Medical Specialty | Cardiovascular |
Review Panel | General Hospital |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Circulatory Support Devices Branch (CSDB) |
Submission Type | 510(k) |
CFR Regulation Number | 870.1670 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | DQF |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
Device Type ID | 2518 |
Device | Actuator, Syringe, Injector Type |
Product Code | DQF |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Syringe Actuator For An Injector. |
CFR Regulation Number | 870.1670 [🔎] |