Device Classification Name |
colonoscope and accessories, flexible/rigid
|
510(k) Number |
K173085 |
Device Name |
invendoscopy E210 System |
Applicant |
invendo medical GmbH |
Peterhofstr. 3 b |
Kissing,
DE
86438
|
|
Applicant Contact |
Oliver v. Ruepprecht |
Correspondent |
invendo medical GmbH |
Peterhofstr. 3 b |
Kissing,
DE
86438
|
|
Correspondent Contact |
Oliver v. Ruepprecht |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 09/29/2017 |
Decision Date | 01/08/2018 |
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
|
|
|