The following data is part of a premarket notification filed by Masimo Corporation with the FDA for Masimo Root Monitoring System.
| Device ID | K140188 |
| 510k Number | K140188 |
| Device Name: | MASIMO ROOT MONITORING SYSTEM |
| 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 |
| Subsequent Product Code | BZQ |
| Subsequent Product Code | CCK |
| Subsequent Product Code | DPZ |
| Subsequent Product Code | DQA |
| Subsequent Product Code | GXY |
| Subsequent Product Code | JKS |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-24 |
| Decision Date | 2014-06-25 |
| Summary: | summary |