Device Classification Name |
endoscopic video imaging system/component, gastroenterology-urology
|
510(k) Number |
K003325 |
Device Name |
KSI'S NEW CAMERA ARCHITECTURE (NCA) VIDEO IMAGING SYSTEM |
Applicant |
KARL STORZ IMAGING, INC. |
175 CREMONA DR. |
GOLETA,
CA
93117
|
|
Applicant Contact |
TERRY FERNANDEZ |
Correspondent |
KARL STORZ IMAGING, INC. |
175 CREMONA DR. |
GOLETA,
CA
93117
|
|
Correspondent Contact |
TERRY FERNANDEZ |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 10/24/2000 |
Decision Date | 04/27/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|