The following data is part of a premarket notification filed by Masimo Corporation with the FDA for Radius T Wearable Thermometer.
| Device ID | K203215 |
| 510k Number | K203215 |
| Device Name: | Radius T Wearable Thermometer |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Masimo Corporation 52 Discovery Irvine, CA 92618 |
| Contact | Sindura Penubarthi |
| Correspondent | Sindura Penubarthi Masimo Corporation 52 Discovery Irvine, CA 92618 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-02 |
| Decision Date | 2021-06-11 |