The following data is part of a premarket notification filed by Invendo Medical Gmbh with the FDA for Invendoscopy E210 System.
| Device ID | K173085 |
| 510k Number | K173085 |
| Device Name: | Invendoscopy E210 System |
| Classification | Colonoscope And Accessories, Flexible/rigid |
| Applicant | invendo Medical GmbH Peterhofstr. 3 B Kissing, DE 86438 |
| Contact | Oliver V. Ruepprecht |
| Correspondent | Oliver V. Ruepprecht invendo Medical GmbH Peterhofstr. 3 B 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 | 2017-09-29 |
| Decision Date | 2018-01-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260444390112 | K173085 | 000 |
| 04260444390082 | K173085 | 000 |
| 04260444390075 | K173085 | 000 |