The following data is part of a premarket notification filed by Masimo Corporation with the FDA for Masimo Root Monitoring System And Accesories.
| Device ID | K142394 |
| 510k Number | K142394 |
| Device Name: | Masimo Root Monitoring System And Accesories |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | MASIMO CORPORATION 40 PARKER Irvine, CA 92618 |
| Contact | Marguerite Thomlinson |
| Correspondent | Marguerite Thomlinson MASIMO CORPORATION 40 PARKER Irvine, CA 92618 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-27 |
| Decision Date | 2014-11-25 |
| Summary: | summary |