Box, Battery, Rechargeable

Device Code: 1755

Product Code(s): FCO

Device Classification Information

Device Type ID1755
Device NameBox, Battery, Rechargeable
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 CodeFCO
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1755
DeviceBox, Battery, Rechargeable
Product CodeFCO
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionEndoscope And Accessories.
CFR Regulation Number876.1500 [🔎]
Device Problems
Battery Problem
12
Device Operates Differently Than Expected
2
Detachment Of Device Or Device Component
2
Smoking
1
Total Device Problems 17
TPLC Last Update: 2019-04-02 19:59:04

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