The following data is part of a premarket notification filed by Ambu A/s with the FDA for Ascope 4 Broncho Regular Sampler Set 5.0/2.2, Ascope 4 Broncho Large Sampler Set 5.8/2.8.
| Device ID | K210883 |
| 510k Number | K210883 |
| Device Name: | AScope 4 Broncho Regular Sampler Set 5.0/2.2, AScope 4 Broncho Large Sampler Set 5.8/2.8 |
| Classification | Bronchoscope (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 | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-25 |
| Decision Date | 2021-06-17 |