The following data is part of a premarket notification filed by Masimo Corporation with the FDA for Masimo Centroid System.
| Device ID | K191882 |
| 510k Number | K191882 |
| Device Name: | Masimo Centroid System |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | Masimo Corporation 52 Discovery Irvine, CA 92618 |
| Contact | Linus Park |
| Correspondent | Linus Park Masimo Corporation 52 Discovery Irvine, CA 92618 |
| Product Code | MWI |
| Subsequent Product Code | BZQ |
| Subsequent Product Code | KMI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-15 |
| Decision Date | 2020-04-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00843997014168 | K191882 | 000 |
| 00843997014151 | K191882 | 000 |
| 00843997012409 | K191882 | 000 |