The following data is part of a premarket notification filed by Ambu A/s with the FDA for Ambu Ascope 4 Rhinolaryngo Slim.
| Device ID | K191080 |
| 510k Number | K191080 |
| Device Name: | Ambu AScope 4 RhinoLaryngo Slim |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| Applicant | Ambu A/S Baltorpbakken 13 Ballerup, DK 2750 |
| Contact | Gurpreet Kaur Rehal |
| Correspondent | Sanjay Parikh Ambu Inc. 6230 Old Dobbin Lane, Suite 250 Columbia, MD 21045 |
| Product Code | EOB |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-24 |
| Decision Date | 2019-05-22 |