The following data is part of a premarket notification filed by Masimo Corporation with the FDA for Masimo Root Monitoring System And Accessories.
| Device ID | K153225 |
| 510k Number | K153225 |
| Device Name: | Masimo Root 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 |
| Subsequent Product Code | BZQ |
| Subsequent Product Code | CCK |
| Subsequent Product Code | DPZ |
| Subsequent Product Code | DQA |
| Subsequent Product Code | GWQ |
| Subsequent Product Code | GXY |
| Subsequent Product Code | OLT |
| Subsequent Product Code | OLW |
| Subsequent Product Code | OMC |
| Subsequent Product Code | ORT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-06 |
| Decision Date | 2016-06-21 |
| Summary: | summary |