The following data is part of a premarket notification filed by Masimo Corporation with the FDA for Rainbow Adhesive Co-oximetry Sensors.
| Device ID | K063140 |
| 510k Number | K063140 |
| Device Name: | RAINBOW ADHESIVE CO-OXIMETRY SENSORS |
| Classification | Oximeter |
| Applicant | MASIMO CORPORATION 40 PARKER Irvine, CA 92618 |
| Contact | James J Cronin |
| Correspondent | James J Cronin 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 | 2006-10-16 |
| Decision Date | 2006-12-29 |
| Summary: | summary |