The following data is part of a premarket notification filed by Ambu A/s with the FDA for Ambu Blue Sensor Neo And Neo X.
| Device ID | K053550 |
| 510k Number | K053550 |
| Device Name: | AMBU BLUE SENSOR NEO AND NEO X |
| Classification | Electrode, Electrocardiograph |
| 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 | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-20 |
| Decision Date | 2006-10-25 |
| Summary: | summary |