Mask, Scavenging

Device Code: 140

Product Code(s): KHA

Device Classification Information

Device Type ID140
Device NameMask, Scavenging
Regulation DescriptionScavenging Mask.
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 Number868.5590 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeKHA
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID140
DeviceMask, Scavenging
Product CodeKHA
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionScavenging Mask.
CFR Regulation Number868.5590 [🔎]
TPLC Last Update: 2019-04-02 19:29:36

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