Table, Operating-room, Mechanical

Device Code: 5549

Product Code(s): FWX

Device Classification Information

Device Type ID5549
Device NameTable, Operating-room, Mechanical
Regulation DescriptionManual Operating Table And Accessories And Manual Operating Chair 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 Number878.4950 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeFWX
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5549
DeviceTable, Operating-room, Mechanical
Product CodeFWX
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionManual Operating Table And Accessories And Manual Operating Chair And Accessories.
CFR Regulation Number878.4950 [🔎]
Device Problems
Unintended Movement
1
Mechanical Problem
1
Use Of Device Problem
1
Total Device Problems 3
TPLC Last Update: 2019-04-02 21:08:18

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