Cleared Traditional

VIDEO OTOSCOPE

K943731 · Cuda Products Co. · Ear, Nose, Throat
Oct 1994
Decision
70d
Days
Class 1
Risk

About This 510(k) Submission

K943731 is an FDA 510(k) clearance for the VIDEO OTOSCOPE, a Otoscope (Class I — General Controls, product code ERA), submitted by Cuda Products Co. (Jacksonville, US). The FDA issued a Cleared decision on October 11, 1994, 70 days after receiving the submission on August 2, 1994. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4770.

Submission Details

510(k) Number K943731 FDA.gov
FDA Decision Cleared SESE
Date Received August 02, 1994
Decision Date October 11, 1994
Days to Decision 70 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