Bottle, Blow

Device Code: 57

Product Code(s): BYO

Device Classification Information

Device Type ID57
Device NameBottle, Blow
Regulation DescriptionBlow Bottle.
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) Exempt
CFR Regulation Number868.5220 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeBYO
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID57
DeviceBottle, Blow
Product CodeBYO
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionBlow Bottle.
CFR Regulation Number868.5220 [🔎]
TPLC Last Update: 2019-04-02 19:27:35

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