The following data is part of a premarket notification filed by Masimo Corporation with the FDA for Masimo Sedline Sedation Monitor And Accessories.
| Device ID | K203113 |
| 510k Number | K203113 |
| Device Name: | Masimo SedLine Sedation Monitor And Accessories |
| Classification | Index-generating Electroencephalograph Software |
| Applicant | Masimo Corporation 52 Discovery Irvine, CA 92618 |
| Contact | Sindura Penubarthi |
| Correspondent | Sindura Penubarthi 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 | 2020-10-15 |
| Decision Date | 2022-02-25 |