Attachment, Binocular, For Endoscope

Device Code: 1787

Product Code(s): FEJ

Device Classification Information

Device Type ID1787
Device NameAttachment, Binocular, For Endoscope
Regulation DescriptionEndoscope And Accessories.
Regulation Medical SpecialtyGastroenterology/Urology
Review PanelGastroenterology/Urology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD)
Urology And Lithotripsy Devices Branch (ULDB)
Submission Type510(K) Exempt
CFR Regulation Number876.1500 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeFEJ
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1787
DeviceAttachment, Binocular, For Endoscope
Product CodeFEJ
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionEndoscope And Accessories.
CFR Regulation Number876.1500 [🔎]
TPLC Last Update: 2019-04-02 19:59:37

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