Cleared Traditional

K851745 - 1-100 UNIVERSAL SET OTOSCOPE & LARYNX EXPLORATON B
(FDA 510(k) Clearance)

K851745 · Artiberia · Ear, Nose, Throat
Aug 1985
Decision
126d
Days
Class 1
Risk

K851745 is an FDA 510(k) clearance for the 1-100 UNIVERSAL SET OTOSCOPE & LARYNX EXPLORATON B, a Otoscope (Class I — General Controls, product code ERA), submitted by Artiberia (San Antonio, US). The FDA issued a Cleared decision on August 29, 1985, 126 days after receiving the submission on April 25, 1985. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4770.

Submission Details

510(k) Number K851745 FDA.gov
FDA Decision Cleared SESE
Date Received April 25, 1985
Decision Date August 29, 1985
Days to Decision 126 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary —

Device Classification

Product Code ERA — Otoscope
Device Class Class I — General Controls
CFR Regulation 21 CFR 874.4770