Cephalometer

Device Code: 5253

Product Code(s): EAG

Device Classification Information

Device Type ID5253
Device NameCephalometer
Regulation DescriptionCephalometer.
Regulation Medical SpecialtyDental
Review PanelRadiology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(k)
CFR Regulation Number872.1830 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeEAG
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 ID5253
DeviceCephalometer
Product CodeEAG
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionCephalometer.
CFR Regulation Number872.1830 [🔎]
TPLC Last Update: 2019-04-02 21:03:03

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