The following data is part of a premarket notification filed by Invendo Medical Gmbh with the FDA for Invendoscopy E200 System.
| Device ID | K161355 |
| 510k Number | K161355 |
| Device Name: | Invendoscopy E200 System |
| Classification | Colonoscope And Accessories, Flexible/rigid |
| Applicant | Invendo Medical GmbH Peterhofstr. 3b Kissing, DE 86438 |
| Contact | Oliver V. Ruepprecht |
| Correspondent | Oliver V. Ruepprecht Invendo Medical GmbH Peterhofstr. 3b Kissing, DE 86438 |
| Product Code | FDF |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-16 |
| Decision Date | 2016-08-25 |
| Summary: | summary |