The following data is part of a premarket notification filed by Masimo Corporation with the FDA for Masimo Resposable Spo2 Series Oximetry Sensors, Masimo Lncs / M-lncs Oximetry Sensors.
| Device ID | K111621 |
| 510k Number | K111621 |
| Device Name: | MASIMO RESPOSABLE SPO2 SERIES OXIMETRY SENSORS, MASIMO LNCS / M-LNCS OXIMETRY SENSORS |
| Classification | Oximeter |
| Applicant | MASIMO CORPORATION 40 PARKER Irvine, CA 92618 |
| Contact | Anil Bhalani |
| Correspondent | Anil Bhalani MASIMO CORPORATION 40 PARKER Irvine, CA 92618 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-10 |
| Decision Date | 2011-10-26 |
| Summary: | summary |