The following data is part of a premarket notification filed by Masimo Corporation with the FDA for Modification To Lncs Oximetry Sensors.
| Device ID | K051212 |
| 510k Number | K051212 |
| Device Name: | MODIFICATION TO LNCS OXIMETRY SENSORS |
| Classification | Oximeter |
| Applicant | MASIMO CORPORATION 40 PARKER Irvine, CA 92618 |
| Contact | James J Cronin |
| Correspondent | James J Cronin 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 | 2005-05-11 |
| Decision Date | 2005-07-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10843997009826 | K051212 | 000 |
| 00843997004435 | K051212 | 000 |
| 00843997003247 | K051212 | 000 |
| 00843997003230 | K051212 | 000 |
| 00843997003209 | K051212 | 000 |
| 00843997003193 | K051212 | 000 |
| 00843997000413 | K051212 | 000 |
| 00843997000406 | K051212 | 000 |
| 00843997000062 | K051212 | 000 |
| 00843997000055 | K051212 | 000 |
| 00843997004923 | K051212 | 000 |
| 00843997007986 | K051212 | 000 |
| 00843997007993 | K051212 | 000 |
| 10843997009154 | K051212 | 000 |
| 10843997004821 | K051212 | 000 |
| 10843997000427 | K051212 | 000 |
| 10843997000373 | K051212 | 000 |
| 00843997016322 | K051212 | 000 |
| 00843997016261 | K051212 | 000 |
| 00843997009850 | K051212 | 000 |
| 00843997009843 | K051212 | 000 |
| 00843997008006 | K051212 | 000 |
| 00843997000048 | K051212 | 000 |