Cleared Traditional

VIVO 200 DPS VIVOSCAN

K003364 · Vivosonic, Inc. · Ear, Nose, Throat

Jul 2001

Decision

264d

Days

Class 2

Risk

About This 510(k) Submission

K003364 is an FDA 510(k) clearance for the VIVO 200 DPS VIVOSCAN, a Audiometer (Class II — Special Controls, product code EWO), submitted by Vivosonic, Inc. (Stamford, US). The FDA issued a Cleared decision on July 18, 2001, 264 days after receiving the submission on October 27, 2000. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.1050.

Submission Details

510(k) Number	K003364 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 27, 2000
Decision Date	July 18, 2001
Days to Decision	264 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF