Device Classification Name |
gastroscope and accessories, flexible/rigid
|
510(k) Number |
K063847 |
Device Name |
FUJINON ULTRASONIC ENDOSCOPE AND PROCESSOR, MODELS EG-530UR, EG-530UT AND SU-700 |
Applicant |
FUJINON, INC. |
543 LONG HILL AVENUE |
SHELTON,
CT
06484
|
|
Applicant Contact |
JOSEPH AZARY |
Correspondent |
FUJINON, INC. |
543 LONG HILL AVENUE |
SHELTON,
CT
06484
|
|
Correspondent Contact |
JOSEPH AZARY |
Regulation Number | 876.1500
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/27/2006 |
Decision Date | 03/01/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|