Cleared Traditional

ENT Nasopharyngoscope and Accessories

K214050 · Medimaging Integrated Solution, Inc (Miis) · Ear, Nose, Throat

Jul 2022

Decision

186d

Days

Class 2

Risk

About This 510(k) Submission

K214050 is an FDA 510(k) clearance for the ENT Nasopharyngoscope and Accessories, a Nasopharyngoscope (flexible Or Rigid) (Class II — Special Controls, product code EOB), submitted by Medimaging Integrated Solution, Inc (Miis) (Hsinchu, TW). The FDA issued a Cleared decision on July 1, 2022, 186 days after receiving the submission on December 27, 2021. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4760.

Submission Details

510(k) Number	K214050 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 27, 2021
Decision Date	July 01, 2022
Days to Decision	186 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF

Device Classification

Product Code	EOB — Nasopharyngoscope (flexible Or Rigid)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 874.4760
Definition	If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).