The following data is part of a premarket notification filed by Masimo Corporation with the FDA for Lncs Oximetry Sensors, Reprocessed Lncs Oximetry Sensors.
| Device ID | K094046 |
| 510k Number | K094046 |
| Device Name: | LNCS OXIMETRY SENSORS, REPROCESSED LNCS OXIMETRY SENSORS |
| Classification | Oximeter |
| Applicant | MASIMO CORPORATION 40 AND 50 PARKER Irvine, CA 92618 |
| Contact | Marguerite Thomlinson |
| Correspondent | Marguerite Thomlinson 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 | 2009-12-31 |
| Decision Date | 2010-05-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00843997003414 | K094046 | 000 |
| 00843997003407 | K094046 | 000 |
| 00843997003391 | K094046 | 000 |
| 00843997003384 | K094046 | 000 |