The following data is part of a premarket notification filed by Masimo Corporation with the FDA for Masimo Set Rad 8 Pulse Oximeter And Accessories, Model Rad 8.
| Device ID | K092838 |
| 510k Number | K092838 |
| Device Name: | MASIMO SET RAD 8 PULSE OXIMETER AND ACCESSORIES, MODEL RAD 8 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-15 |
| Decision Date | 2009-10-15 |
| Summary: | summary |