The following data is part of a premarket notification filed by Masimo Corporation with the FDA for Masimo Lnop/lncs/m-lncs Multisite-l Oximetry Sensors.
| Device ID | K111888 |
| 510k Number | K111888 |
| Device Name: | MASIMO LNOP/LNCS/M-LNCS MULTISITE-L OXIMETRY SENSORS |
| Classification | Oximeter |
| Applicant | MASIMO CORPORATION 40 AND 50 PARKER Irvine, CA 92618 |
| Contact | Anil Bhalani |
| Correspondent | Anil Bhalani 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 | 2011-07-01 |
| Decision Date | 2011-09-23 |
| Summary: | summary |