The following data is part of a premarket notification filed by Masimo Corporation with the FDA for Masimo Rad-97 Pulse Co-oximeter And Accessories, Masimo Radical-7 Pulse Co-oximeter And Accessories, Masimo Radius-7 Pulse Co-oximeter And Accessories.
| Device ID | K193242 |
| 510k Number | K193242 |
| Device Name: | Masimo Rad-97 Pulse CO-Oximeter And Accessories, Masimo Radical-7 Pulse CO-Oximeter And Accessories, Masimo Radius-7 Pulse CO-Oximeter And Accessories |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | Masimo Corporation 52 Discovery Irvine, CA 92618 |
| Contact | Sindura Penubarthi |
| Correspondent | Sindura Penubarthi 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 | DXN |
| Subsequent Product Code | FLL |
| Subsequent Product Code | JKS |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-25 |
| Decision Date | 2020-02-27 |