Accessory To Continuous Ventilator (respirator)

Device Code: 150

Product Code(s): MOD

Device Classification Information

Device Type ID150
Device NameAccessory To Continuous Ventilator (respirator)
Regulation DescriptionContinuous Ventilator.
Regulation Medical SpecialtyAnesthesiology
Review PanelAnesthesiology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID)
Respiratory Devices Branch (RPDB)
Submission Type510(k)
CFR Regulation Number868.5895 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeMOD
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 ID150
DeviceAccessory To Continuous Ventilator (respirator)
Product CodeMOD
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionContinuous Ventilator.
CFR Regulation Number868.5895 [🔎]
Premarket Reviews
ManufacturerDecision
PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV
 
SUBSTANTIALLY EQUIVALENT
1
RESPIRONICS, INC.
 
SUBSTANTIALLY EQUIVALENT
1
TPLC Last Update: 2019-04-02 19:29:46

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