Attachment, Eyepiece, For Insertion Of Prescription Lens

Device Code: 1779

Product Code(s): FDZ

Device Classification Information

Device Type ID1779
Device NameAttachment, Eyepiece, For Insertion Of Prescription Lens
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 CodeFDZ
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1779
DeviceAttachment, Eyepiece, For Insertion Of Prescription Lens
Product CodeFDZ
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionEndoscope And Accessories.
CFR Regulation Number876.1500 [🔎]
TPLC Last Update: 2019-04-02 19:59:30

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