Device Classification Name |
colonoscope and accessories, flexible/rigid
|
510(k) Number |
K190669 |
Device Name |
Endotics |
Applicant |
Era Endoscopy s.r.l. |
Via Boccioni, 1 |
Peccioli,
IT
56037
|
|
Applicant Contact |
Alberto Arena |
Correspondent |
Era Endoscopy s.r.l. |
Via Boccioni, 1 |
Peccioli,
IT
56037
|
|
Correspondent Contact |
Alberto Arena |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 03/15/2019 |
Decision Date | 01/03/2020 |
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
|
|
|