K233779

LoopView® Single-Use Digital Flexible Bronchoscope (B38, B38-C, B50, B50-C, B58, B58-C), ViewHub® Video Processor (S13)

510(k) number: K233779
Device name: LoopView® Single-Use Digital Flexible Bronchoscope (B38, B38-C, B50, B50-C, B58, B58-C), ViewHub® Video Processor (S13)
Applicant: MacroLux Medical Technology Co., Ltd. CN
Product code: EOQ — Bronchoscope (Flexible Or Rigid)
Decision date: 2024-04-05
Date received: 2023-11-27
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: Ear, Nose, Throat

510(k) Summary (official FDA PDF): K233779.pdf

Official FDA record: K233779

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.