Cleared Traditional

K944031 - VIDEO SCOPE SYSTEM (OTOSCOPE)
(FDA 510(k) Clearance)

K944031 · Jedmed Instrument Co. · Ear, Nose, Throat device

Sep 1994

Decision

37d

Days

Class 1

Risk

K944031 is an FDA 510(k) clearance for the VIDEO SCOPE SYSTEM (OTOSCOPE). This device is classified as a Otoscope (Class I - General Controls, product code ERA).

Submitted by Jedmed Instrument Co. (St.Louis, US). The FDA issued a Cleared decision on September 23, 1994, 37 days after receiving the submission on August 17, 1994.

This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4770.

Submission Details

510(k) Number	K944031 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 17, 1994
Decision Date	September 23, 1994
Days to Decision	37 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Statement