Cleared Traditional

ORL Video NasoPharyngo-Larngoscope

K150248 · Jedmed Instrument Company · Ear, Nose, Throat

Jul 2015

Decision

170d

Days

Class 2

Risk

About This 510(k) Submission

K150248 is an FDA 510(k) clearance for the ORL Video NasoPharyngo-Larngoscope, a Laryngoscope, Nasopharyngoscope (Class II — Special Controls, product code EQN), submitted by Jedmed Instrument Company (Saint Louis, US). The FDA issued a Cleared decision on July 23, 2015, 170 days after receiving the submission on February 3, 2015. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4760.

Submission Details

510(k) Number	K150248 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 03, 2015
Decision Date	July 23, 2015
Days to Decision	170 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF

Device Classification

Product Code	EQN — Laryngoscope, Nasopharyngoscope
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).