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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00843997010894 | K071024 | 000 |
| 10843997001455 | K071024 | 000 |
| 10843997001462 | K071024 | 000 |
| 10843997001479 | K071024 | 000 |
| 10843997001684 | K071024 | 000 |
| 10843997002759 | K071024 | 000 |
| 10843997002766 | K071024 | 000 |
| 10843997004067 | K071024 | 000 |
| 10843997004074 | K071024 | 000 |
| 00843997010863 | K071024 | 000 |
| 00843997010870 | K071024 | 000 |
| 00843997010887 | K071024 | 000 |
| 10843997001448 | K071024 | 000 |