The following data is part of a premarket notification filed by Masimo Corporation with the FDA for Masimo Responsable Oximetry Sensors Model S2-25/25d; S2-20/20d.
| Device ID | K100617 |
| 510k Number | K100617 |
| Device Name: | MASIMO RESPONSABLE OXIMETRY SENSORS MODEL S2-25/25D; S2-20/20D |
| 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 |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-04 |
| Decision Date | 2010-05-28 |
| Summary: | summary |