Chamber, Oxygen, Topical, Extremity

Device Code: 5721

Product Code(s): KPJ

Device Classification Information

Device Type ID5721
Device NameChamber, Oxygen, Topical, Extremity
Regulation DescriptionTopical Oxygen Chamber For Extremities.
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 One - Light Based/Laser (GSDB1)
Submission Type510(k)
CFR Regulation Number878.5650 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeKPJ
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5721
DeviceChamber, Oxygen, Topical, Extremity
Product CodeKPJ
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionTopical Oxygen Chamber For Extremities.
CFR Regulation Number878.5650 [🔎]
TPLC Last Update: 2019-04-02 21:11:24

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