The following data is part of a premarket notification filed by Masimo Corporation with the FDA for Rainbow Resposable Pulse Co-oximeter Sensors, Models R2c-25, R2-25, R2c-20 And R2-20.
| Device ID | K090165 |
| 510k Number | K090165 |
| Device Name: | RAINBOW RESPOSABLE PULSE CO-OXIMETER SENSORS, MODELS R2C-25, R2-25, R2C-20 AND R2-20 |
| 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 | DSA |
| Subsequent Product Code | JKS |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-22 |
| Decision Date | 2009-07-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10843997007396 | K090165 | 000 |
| 10843997007389 | K090165 | 000 |
| 10843997007198 | K090165 | 000 |
| 10843997007181 | K090165 | 000 |
| 10843997003725 | K090165 | 000 |
| 10843997003701 | K090165 | 000 |