IMAGE1 GI CCU MODEL 22203020-114


Device Classification Name

endoscopic video imaging system/component, gastroenterology-urology

510(k) Number K111997
Device Name IMAGE1 GI CCU MODEL 22203020-114
Applicant
KARL STORZ ENDOSCOPY-AMERICA, INC.
2151 e. grand ave.
el segundo, 
CA 
90245

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

Correspodent Contact winkie wong
Regulation Number 876.1500
Classification Product Code
FET  
Date Received 07/13/2011
Decision Date 04/06/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No