K243497

Portable Video Processor (EA101), Flexible Bronchoscope BS41H-12EU, BS41H-12US, BS46H-17EU, BS50H-20EU, BS46H-17US, BS50H-20US, BS53H-22EU, BS53H-22US, BS55H-24EU, BS55H-24US, BS59H-28EU, BS59H-28US

510(k) number: K243497
Device name: Portable Video Processor (EA101), Flexible Bronchoscope BS41H-12EU, BS41H-12US, BS46H-17EU, BS50H-20EU, BS46H-17US, BS50H-20US, BS53H-22EU, BS53H-22US, BS55H-24EU, BS55H-24US, BS59H-28EU, BS59H-28US
Applicant: Shanghai AnQing Medical Instrument Co., Ltd. CN
Product code: EOQ — Bronchoscope (Flexible Or Rigid)
Decision date: 2025-05-29
Date received: 2024-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: Ear, Nose, Throat

510(k) Summary (official FDA PDF): K243497.pdf

Official FDA record: K243497

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