VIEW 1 IMAGING


Device Classification Name

system, image processing, radiological

510(k) Number K112480
Device Name VIEW 1 IMAGING
Applicant
KARL STORZ ENDOSCOPY AMERICA, INC.
2151 e. grand avenue
el segundo, 
CA 
90245

Applicant Contact winkie wong
Correspondent
KARL STORZ ENDOSCOPY AMERICA, INC.
2151 e. grand avenue
el segundo, 
CA 
90245

Correspodent Contact winkie wong
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 08/29/2011
Decision Date 12/13/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No