The following data is part of a premarket notification filed by Masimo Corporation with the FDA for M-lncs Oximetry Sensors, Reprocessed M-lncs Oximetry Sensors.
| Device ID | K110723 |
| 510k Number | K110723 |
| Device Name: | M-LNCS OXIMETRY SENSORS, REPROCESSED M-LNCS OXIMETRY SENSORS |
| Classification | Oximeter, Reprocessed |
| Applicant | MASIMO CORPORATION 40 PARKER Irvine, CA 92618 |
| Contact | Shelly Harris |
| Correspondent | Shelly Harris MASIMO CORPORATION 40 PARKER Irvine, CA 92618 |
| Product Code | NLF |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DSA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-16 |
| Decision Date | 2011-07-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10843997004777 | K110723 | 000 |
| 10843997004760 | K110723 | 000 |
| 10843997004753 | K110723 | 000 |
| 10843997004739 | K110723 | 000 |
| 10843997004722 | K110723 | 000 |
| 10843997004715 | K110723 | 000 |