The following data is part of a premarket notification filed by Ambu A/s with the FDA for Ambu Blue Sensor Neo, Ambu Blue Sensor Neo X.
| Device ID | K100129 |
| 510k Number | K100129 |
| Device Name: | AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR 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 | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-19 |
| Decision Date | 2010-06-11 |
| Summary: | summary |