The following data is part of a premarket notification filed by Ambu A/s with the FDA for Ambu Ascope 3 Regular 5.0/2.2, Ambu Ascope 3 Slim 3.8/1.2, Ambu Ascope 3 Large 5.8/2.8, Ambu Aview Monitor.
| Device ID | K161656 |
| 510k Number | K161656 |
| Device Name: | Ambu AScope 3 Regular 5.0/2.2, Ambu AScope 3 Slim 3.8/1.2, Ambu AScope 3 Large 5.8/2.8, Ambu AView Monitor |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | AMBU A/S BALTORPBAKKEN 13 Ballerup, DK Dk-2750 |
| Contact | Camilla Wismar |
| 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 | 2016-06-16 |
| Decision Date | 2016-09-01 |
| Summary: | summary |