VIVOSONIC NEUROSCREEN


Device Classification Name

stimulator, auditory, evoked response

510(k) Number K080060
Device Name VIVOSONIC NEUROSCREEN
Applicant
VIVOSONIC, INC.
120-5525 eglinton avenue west
toronto, on, 

CA

m9c 5k5

Applicant Contact amjad rana
Correspondent
VIVOSONIC, INC.
120-5525 eglinton avenue west
toronto, on, 

CA

m9c 5k5

Correspodent Contact amjad rana
Regulation Number 882.1900
Classification Product Code
GWJ  
Date Received 01/09/2008
Decision Date 04/04/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Ear Nose & Throat

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No