The following data is part of a premarket notification filed by Ambu A/s with the FDA for Ambu Ascope 3 Slim 3.8/1.2 And Ambu Ascope 4 Broncho Slim 3.8/1.2; Ambu Ascope 3 Regular 5.0/2.2 And Ambu Ascope 4 Broncho Regular 5.0/2.2; Ambu Ascope 3 Large 5.8/2.8 And Ambu Ascope 4 Broncho Large 5.8/2.8; Ambu Aview Monitor.
| Device ID | K173727 |
| 510k Number | K173727 |
| Device Name: | Ambu AScope 3 Slim 3.8/1.2 And Ambu AScope 4 Broncho Slim 3.8/1.2; Ambu AScope 3 Regular 5.0/2.2 And Ambu AScope 4 Broncho Regular 5.0/2.2; Ambu AScope 3 Large 5.8/2.8 And Ambu AScope 4 Broncho Large 5.8/2.8; Ambu AView Monitor |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | Ambu A/S Baltorpbakken 13 Ballerup, DK 2750 |
| Contact | Maja Brons |
| Correspondent | Sanjay Parikh Ambu Inc. 6230 Old Dobbin Lane Suite 250 Colombia, MD 21045 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-05 |
| Decision Date | 2018-03-28 |
| Summary: | summary |