The following data is part of a premarket notification filed by Ambu A/s with the FDA for Ambu Usr, Ambu M.
| Device ID | K160766 |
| 510k Number | K160766 |
| Device Name: | Ambu USR, Ambu M |
| Classification | Cystoscope And Accessories, Flexible/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 | FAJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-21 |
| Decision Date | 2016-08-17 |
| Summary: | summary |