Absorber, Carbon-dioxide

Device Code: 5

Product Code(s): BSF

Device Classification Information

Device Type ID5
Device NameAbsorber, Carbon-dioxide
Regulation DescriptionCarbon Dioxide Absorber.
Regulation Medical SpecialtyAnesthesiology
Review PanelAnesthesiology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID)
Anesthesiology Devices Branch (ANDB)
Submission Type510(K) Exempt
CFR Regulation Number868.5310 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeBSF
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5
DeviceAbsorber, Carbon-dioxide
Product CodeBSF
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionCarbon Dioxide Absorber.
CFR Regulation Number868.5310 [🔎]
Device Problems
Insufficient Information
1
Adverse Event Without Identified Device Or Use Problem
1
Total Device Problems 2
TPLC Last Update: 2019-04-02 19:16:50

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