Atlas FDA

FEJ

1 FDA 510(k) clearances · Product code

FDA profile

Official device name
Attachment, Binocular, For Endoscope
Device class
Class I (low risk)
Regulation
21 CFR 876.1500
Medical specialty
Gastroenterology, Urology
Adverse events (MAUDE)
2000: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDateBuilder
TBI TRAINER (K840837)Manico1985-03-25+ Add

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