Cleared Traditional

ERGO-FLEX LARYNGO-NASOPHARYNGOSCOPE EF-N AND EF-N SLIM

K132039 · Jedmed Instrument Co. · Ear, Nose, Throat

Feb 2014

Decision

234d

Days

Class 2

Risk

About This 510(k) Submission

K132039 is an FDA 510(k) clearance for the ERGO-FLEX LARYNGO-NASOPHARYNGOSCOPE EF-N AND EF-N SLIM, a Laryngoscope, Nasopharyngoscope (Class II — Special Controls, product code EQN), submitted by Jedmed Instrument Co. (St. Louis, US). The FDA issued a Cleared decision on February 21, 2014, 234 days after receiving the submission on July 2, 2013. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4760.

Submission Details

510(k) Number	K132039 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 02, 2013
Decision Date	February 21, 2014
Days to Decision	234 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).