Cleared Traditional

K831255 - LARYNGOSCOPE ATTACHMENT PH2000
(FDA 510(k) Clearance)

K831255 · Eder Instrument Co, Inc. · Ear, Nose, Throat

Sep 1983

Decision

147d

Days

Class 2

Risk

K831255 is an FDA 510(k) clearance for the LARYNGOSCOPE ATTACHMENT PH2000, a Laryngoscope, Nasopharyngoscope (Class II — Special Controls, product code EQN), submitted by Eder Instrument Co, Inc. (Milwaukee, Wi 53202, US). The FDA issued a Cleared decision on September 12, 1983, 147 days after receiving the submission on April 18, 1983. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4760.

Submission Details

510(k) Number	K831255 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 18, 1983
Decision Date	September 12, 1983
Days to Decision	147 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	—

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).