The following data is part of a premarket notification filed by Masimo Corporation with the FDA for Masimo Root Vital Signs Monitoring System And Accessories.
| Device ID | K151644 |
| 510k Number | K151644 |
| Device Name: | Masimo Root Vital Signs Monitoring System And Accessories |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | MASIMO CORPORATION 52 DISCOVERY Irvine, CA 92618 |
| Contact | Marguerite Thomlinson |
| Correspondent | Marguerite Thomlinson MASIMO CORPORATION 52 DISCOVERY 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 | 2015-06-18 |
| Decision Date | 2016-02-12 |
| Summary: | summary |