Device Classification Name |
endoscopic video imaging system/component, gastroenterology-urology
|
510(k) Number |
K180414 |
Device Name |
EPX-4440FN Digital Video Processor with Light Source |
Applicant |
FUJIFILM New Development U.S.A., Inc. |
318 Bear Hill Road |
Waltham,
MA
02451
|
|
Applicant Contact |
Stephen Mariano |
Correspondent |
O'Connell Regulatory Consultants, Inc. |
5 Timber Lane |
North Reading,
MA
01864
|
|
Correspondent Contact |
Maureen O'Connell |
Regulation Number | 876.1500
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 02/15/2018 |
Decision Date | 05/24/2018 |
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
|
|
|