The following data is part of a premarket notification filed by Nonin Medical, Inc. with the FDA for Sensmart Model 8006ca Reusable Regional Oximetry Sensor, Sensmart Model 8006pi Disposable Patient Interface.
| Device ID | K190560 |
| 510k Number | K190560 |
| Device Name: | SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface |
| Classification | Oximeter, Tissue Saturation |
| Applicant | Nonin Medical, Inc. 13700 1st Avenue North Plymouth, MN 55441 |
| Contact | Nancy Deangelo |
| Correspondent | Nancy Deangelo Nonin Medical, Inc. 13700 1st Avenue North Plymouth, MN 55441 |
| Product Code | MUD |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-05 |
| Decision Date | 2019-05-02 |