Cleaner, Air, Medical Recirculating

Device Code: 2596

Product Code(s): FRF

Device Classification Information

Device Type ID2596
Device NameCleaner, Air, Medical Recirculating
Regulation DescriptionMedical Recirculating Air Cleaner.
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 Number880.5045 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeFRF
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 ID2596
DeviceCleaner, Air, Medical Recirculating
Product CodeFRF
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionMedical Recirculating Air Cleaner.
CFR Regulation Number880.5045 [🔎]
TPLC Last Update: 2019-04-02 20:15:43

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