The following data is part of a premarket notification filed by Ambu A/s with the FDA for Ambu Oval Silicone Resuscitator, Adult And Pediatric.
| Device ID | K102824 |
| 510k Number | K102824 |
| Device Name: | AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRIC |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| 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 | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-29 |
| Decision Date | 2011-01-28 |
| Summary: | summary |