The following data is part of a premarket notification filed by Masimo Corporation with the FDA for Rainbow Adhesive Co-oximetry Sensor, Models Ri-25-l, Ri-25, Ri-20 And Ri-20-l.
| Device ID | K081659 |
| 510k Number | K081659 |
| Device Name: | RAINBOW ADHESIVE CO-OXIMETRY SENSOR, MODELS RI-25-L, RI-25, RI-20 AND RI-20-L |
| 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 |
| Subsequent Product Code | DPZ |
| Subsequent Product Code | JKS |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-12 |
| Decision Date | 2008-09-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00843997017923 | K081659 | 000 |
| 10843997002322 | K081659 | 000 |
| 10843997002339 | K081659 | 000 |
| 10843997002346 | K081659 | 000 |
| 10843997002353 | K081659 | 000 |
| 00843997010900 | K081659 | 000 |
| 00843997010917 | K081659 | 000 |
| 00843997010924 | K081659 | 000 |
| 00843997010931 | K081659 | 000 |
| 10843997012413 | K081659 | 000 |
| 00843997015745 | K081659 | 000 |
| 00843997015752 | K081659 | 000 |
| 00843997015769 | K081659 | 000 |
| 00843997015776 | K081659 | 000 |
| 00843997015943 | K081659 | 000 |