Device Classification Name |
Endoscopic Video Imaging System/Component, Gastroenterology-Urology
|
510(k) Number |
K131953 |
Device Name |
IMAGE1 SPIES |
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
|
|
Correspondent Contact |
WINKIE WONG |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 06/27/2013 |
Decision Date | 12/20/2013 |
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
|
Recalls |
CDRH Recalls
|
|
|