BALL RECORDING ELECTRODE/STIMULATION PROBE


Device Classification Name

electrode, nasopharyngeal

510(k) Number K030517
Device Name BALL RECORDING ELECTRODE/STIMULATION PROBE
Applicant
VIASYS HEALTHCARE, INC.
800 levanger ln.
stoughton, 
WI 
53589

Applicant Contact gary syring
Correspondent
VIASYS HEALTHCARE, INC.
800 levanger ln.
stoughton, 
WI 
53589

Correspodent Contact gary syring
Regulation Number 882.1340
Classification Product Code
GZK  
Date Received 02/19/2003
Decision Date 08/01/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

Type Abbreviated
Reviewed by Third Party No

Combination Product

No