FDA 510(k), K201146, Ion Endoluminal System

FDA 510(k), K201146, Ion Endoluminal System

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510(K) Number: K201146
Device Name: Ion Endoluminal System
Manufacturer: Jennifer Siu
Device Classification Name: Bronchoscope (Flexible Or Rigid)
Regulation Number: EOQ
Classification Product Code: 04/29/2020
Date Received: 06/26/2020
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ear Nose & Throat

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