Chamber, Patient Transport Isolation

Device Code: 2651

Product Code(s): LGN

Device Classification Information

Device Type ID2651
Device NameChamber, Patient Transport Isolation
Regulation DescriptionPatient Care Reverse Isolation Chamber.
Regulation Medical SpecialtyGeneral Hospital
Review PanelGeneral Hospital
Premarket Review Office Of Device Evaluation (ODE)
Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID)
Infection Control Devices Branch (INCB)
Submission Type510(k)
CFR Regulation Number880.5450 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeLGN
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 ID2651
DeviceChamber, Patient Transport Isolation
Product CodeLGN
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionPatient Care Reverse Isolation Chamber.
CFR Regulation Number880.5450 [🔎]
TPLC Last Update: 2019-04-02 20:16:44

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