Airbrush

Device Code: 1289

Product Code(s): KOJ

Device Classification Information

Device Type ID1289
Device NameAirbrush
Regulation DescriptionAirbrush.
Regulation Medical SpecialtyDental
Review PanelDental
Premarket Review Office Of Device Evaluation (ODE)
Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID)
Dental Devices Branch (DEDB)
Submission Type510(k)
CFR Regulation Number872.6080 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeKOJ
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 ID1289
DeviceAirbrush
Product CodeKOJ
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionAirbrush.
CFR Regulation Number872.6080 [🔎]
Device Problems
Excess Flow Or Over-Infusion
1
Improper Or Incorrect Procedure Or Method
1
Device Operates Differently Than Expected
1
Total Device Problems 3
TPLC Last Update: 2019-04-02 19:51:25

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