Cleared Special

VIVO 200 DPS VIVOSCAN VERSION 2.0 OAE AUDIOMETER

K033108 · Vivosonic, Inc. · Ear, Nose, Throat

Oct 2003

Decision

27d

Days

Class 2

Risk

About This 510(k) Submission

K033108 is an FDA 510(k) clearance for the VIVO 200 DPS VIVOSCAN VERSION 2.0 OAE AUDIOMETER, a Audiometer (Class II — Special Controls, product code EWO), submitted by Vivosonic, Inc. (Toronto, On, CA). The FDA issued a Cleared decision on October 27, 2003, 27 days after receiving the submission on September 30, 2003. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.1050.

Submission Details

510(k) Number	K033108 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 30, 2003
Decision Date	October 27, 2003
Days to Decision	27 days
Submission Type	Special
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF