K242416

Single-use Flexible Bronchoscope: BC-E1C10, BC-E1C11, BC-E1C12, BC-E1E10, BC-E1E11, BC-E1E12, BC-E1H10, BC-E1H11, BC-E1H12; Digital Video Monitor: DVM-D1, DVM-D2; Single-use sampler: S-20mL, S-30mL, S-50mL

510(k) number: K242416
Device name: Single-use Flexible Bronchoscope: BC-E1C10, BC-E1C11, BC-E1C12, BC-E1E10, BC-E1E11, BC-E1E12, BC-E1H10, BC-E1H11, BC-E1H12; Digital Video Monitor: DVM-D1, DVM-D2; Single-use sampler: S-20mL, S-30mL, S-50mL
Applicant: Hunan Vathin Medical Instrument Co., Ltd. CN
Product code: EOQ — Bronchoscope (Flexible Or Rigid)
Decision date: 2025-01-16
Date received: 2024-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: Ear, Nose, Throat

510(k) Summary (official FDA PDF): K242416.pdf

Official FDA record: K242416

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