Device Classification Name |
endoscopic video imaging system/component, gastroenterology-urology
|
510(k) Number |
K934623 |
Device Name |
ENDOSCOPIC VIDEO SYSTEM AND ENDOSCOPIC VIDEO CAMERA |
Applicant |
ENDOMEDIX |
2162 MICHELSON DR. |
IRVINE,
CA
92715 -1304
|
|
Applicant Contact |
RANDY A WILSON |
Correspondent |
ENDOMEDIX |
2162 MICHELSON DR. |
IRVINE,
CA
92715 -1304
|
|
Correspondent Contact |
RANDY A WILSON |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 09/27/1993 |
Decision Date | 12/02/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|