Table, Operating-room, Pneumatic

Device Code: 5548

Product Code(s): FWW

Device Classification Information

Device Type ID5548
Device NameTable, Operating-room, Pneumatic
Regulation DescriptionOperating Tables And Accessories And Operating Chairs And Accessories.
Regulation Medical SpecialtyGeneral & Plastic Surgery
Review PanelGeneral & Plastic Surgery
Premarket Review Office Of Device Evaluation (ODE)
Division Of Surgical Devices (DSD)
General Surgery Devices Branch Two - Surgical (GSDB2)
Submission Type510(K) Exempt
CFR Regulation Number878.4960 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeFWW
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5548
DeviceTable, Operating-room, Pneumatic
Product CodeFWW
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionOperating Tables And Accessories And Operating Chairs And Accessories.
CFR Regulation Number878.4960 [🔎]
TPLC Last Update: 2019-04-02 21:08:17

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