The following data is part of a premarket notification filed by Masimo Corporation with the FDA for Masimo Rainbow Set Radical 7r Pulse Co-oximeter.
| Device ID | K100428 |
| 510k Number | K100428 |
| Device Name: | MASIMO RAINBOW SET RADICAL 7R PULSE CO-OXIMETER |
| Classification | Oximeter |
| Applicant | MASIMO CORPORATION 40 PARKER Irvine, CA 92618 |
| Contact | Marguerite Thomlinson |
| Correspondent | Marguerite Thomlinson MASIMO CORPORATION 40 PARKER Irvine, CA 92618 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-16 |
| Decision Date | 2010-07-09 |
| Summary: | summary |