The following data is part of a premarket notification filed by Ambu A/s with the FDA for Ambu Ascope And Monitor.
| Device ID | K093186 |
| 510k Number | K093186 |
| Device Name: | AMBU ASCOPE AND MONITOR |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | AMBU A/S 6740 BAYMEADOW DR. Glen Burnie, MD 21060 |
| Contact | Sanjay Parikh |
| Correspondent | Sanjay Parikh AMBU A/S 6740 BAYMEADOW DR. Glen Burnie, MD 21060 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-09 |
| Decision Date | 2010-04-16 |
| Summary: | summary |