VSU – VISIONSENSE STEREOSCOPIC VISION SYSTEM


Device Classification Name

endoscope, neurological

510(k) Number K081102
Device Name VSU – VISIONSENSE STEREOSCOPIC VISION SYSTEM
Applicant
VISIONSENSE, LTD.
555 13th street, nw
washington, 
DC 
20004

Applicant Contact gerard j prud’homme
Correspondent
VISIONSENSE, LTD.
555 13th street, nw
washington, 
DC 
20004

Correspodent Contact gerard j prud’homme
Regulation Number 882.1480
Classification Product Code
GWG  
Date Received 04/17/2008
Decision Date 05/29/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls