The following data is part of a premarket notification filed by Masimo Corporation with the FDA for Masimo Rad-g Pulse Oximeter, Masimo Rad-g Yi Sensor, Masimo Rad-g Reusable Sensor.
| Device ID | K201770 |
| 510k Number | K201770 |
| Device Name: | Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI Sensor, Masimo Rad-G Reusable Sensor |
| Classification | Oximeter |
| Applicant | Masimo Corporation 52 Discovery Irvine, CA 92618 |
| Contact | Katelynn Kirby |
| Correspondent | Katelynn Kirby Masimo Corporation 52 Discovery Irvine, CA 92618 |
| Product Code | DQA |
| Subsequent Product Code | BZQ |
| Subsequent Product Code | DPZ |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-29 |
| Decision Date | 2020-09-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00843997016056 | K201770 | 000 |
| 00843997016049 | K201770 | 000 |
| 00843997016032 | K201770 | 000 |
| 00843997015530 | K201770 | 000 |
| 00843997013284 | K201770 | 000 |
| 00843997013123 | K201770 | 000 |
| 00843997000666 | K201770 | 000 |