Attachment, Intermittent Mandatory Ventilation (imv)

Device Code: 103

Product Code(s): CBO

Device Classification Information

Device Type ID103
Device NameAttachment, Intermittent Mandatory Ventilation (imv)
Regulation DescriptionIntermittent Mandatory Ventilation Attachment.
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)
CFR Regulation Number868.5955 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeCBO
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceYes
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID103
DeviceAttachment, Intermittent Mandatory Ventilation (imv)
Product CodeCBO
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionIntermittent Mandatory Ventilation Attachment.
CFR Regulation Number868.5955 [🔎]
TPLC Last Update: 2019-04-02 19:29:06

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.