Device Classification Name |
Endoscopic Video Imaging System/Component, Gastroenterology-Urology
|
510(k) Number |
K160044 |
FOIA Releasable 510(k) |
K160044
|
Device Name |
Image1 SPIES System |
Applicant |
KARL STORZ ENDOSCOPY AMERICA, INC. |
2151 E. GRAND AVE |
EL SEGUNDO,
CA
90245
|
|
Applicant Contact |
SUSIE S. CHEN |
Correspondent |
KARL STORZ ENDOSCOPY AMERICA, INC. |
2151 E. GRAND AVE |
EL SEGUNDO,
CA
90245
|
|
Correspondent Contact |
WINKIE WONG |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 01/08/2016 |
Decision Date | 02/01/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|