Actuator, Syringe, Injector Type

Device Code: 2518

Product Code(s): DQF

Device Classification Information

Device Type ID2518
Device NameActuator, Syringe, Injector Type
Regulation DescriptionSyringe Actuator For An Injector.
Regulation Medical SpecialtyCardiovascular
Review PanelGeneral Hospital
Premarket Review Office Of Device Evaluation (ODE)
Division Of Cardiovascular Devices (DCD)
Circulatory Support Devices Branch (CSDB)
Submission Type510(k)
CFR Regulation Number870.1670 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeDQF
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

Device Type ID2518
DeviceActuator, Syringe, Injector Type
Product CodeDQF
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionSyringe Actuator For An Injector.
CFR Regulation Number870.1670 [🔎]
TPLC Last Update: 2019-04-02 20:13:40

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