The following data is part of a premarket notification filed by Ambu A/s with the FDA for Ambu Ascope 4 Cysto.
| Device ID | K193095 |
| 510k Number | K193095 |
| Device Name: | Ambu AScope 4 Cysto |
| Classification | Cystoscope And Accessories, Flexible/rigid |
| Applicant | Ambu A/S Baltorpbakken 13 Ballerup, DK 2750 |
| Contact | Anita Fjaestad |
| Correspondent | Sanjay Parikh Ambu Inc. 6230 Old Dobbin Lane, Suite 250 Columbia, MD 21045 |
| Product Code | FAJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-07 |
| Decision Date | 2020-04-02 |