Cleared Traditional

K950788 - OTOSCOPE A-34
(FDA 510(k) Clearance)

K950788 · Neitz Instruments Company, Ltd. · Ear, Nose, Throat
May 1995
Decision
71d
Days
Class 1
Risk

K950788 is an FDA 510(k) clearance for the OTOSCOPE A-34, a Otoscope (Class I — General Controls, product code ERA), submitted by Neitz Instruments Company, Ltd. (Tokyo, JP). The FDA issued a Cleared decision on May 3, 1995, 71 days after receiving the submission on February 21, 1995. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4770.

Submission Details

510(k) Number K950788 FDA.gov
FDA Decision Cleared SESE
Date Received February 21, 1995
Decision Date May 03, 1995
Days to Decision 71 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement

Device Classification

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