The following data is part of a premarket notification filed by Masimo Corporation with the FDA for Sedline Sedation Monitor.
| Device ID | K172890 |
| 510k Number | K172890 |
| Device Name: | SedLine Sedation Monitor |
| Classification | Index-generating Electroencephalograph Software |
| Applicant | Masimo Corporation 52 Discovery Irvine, CA 92618 |
| Contact | Matthew Tiacharoen |
| Correspondent | Matthew Tiacharoen Masimo Corporation 52 Discovery Irvine, CA 92618 |
| Product Code | OLW |
| Subsequent Product Code | GXY |
| Subsequent Product Code | OLT |
| Subsequent Product Code | OMC |
| Subsequent Product Code | ORT |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-22 |
| Decision Date | 2018-01-26 |
| Summary: | summary |