The following data is part of a premarket notification filed by Masimo Corporation with the FDA for Modification To: Rainbow Adhesive Co-oximetry Sensors.
| Device ID | K071024 |
| 510k Number | K071024 |
| Device Name: | MODIFICATION TO: RAINBOW ADHESIVE CO-OXIMETRY SENSORS |
| Classification | Oximeter |
| Applicant | MASIMO CORPORATION 40 AND 50 PARKER Irvine, CA 92618 |
| Contact | James J Cronin |
| Correspondent | James J Cronin MASIMO CORPORATION 40 AND 50 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 | 2007-04-11 |
| Decision Date | 2007-06-29 |
| Summary: | summary |