The following data is part of a premarket notification filed by Ambu Innovation Gmbh with the FDA for Ambu Duodeno System.
| Device ID | K201098 |
| 510k Number | K201098 |
| Device Name: | Ambu Duodeno System |
| Classification | Duodenoscope And Accessories, Flexible/rigid |
| Applicant | Ambu Innovation GmbH Peterhofstr 3b Kissing, DE 86438 |
| Contact | Oliver V Ruepprecht |
| Correspondent | Sanjay Parikh Ambu Inc. 6230 Old Dobbin Lane Suite 250 Columbia, MD 21045 |
| Product Code | FDT |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-24 |
| Decision Date | 2020-07-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05707480145362 | K201098 | 000 |
| 05707480145270 | K201098 | 000 |
| 05707480157426 | K201098 | 000 |