Stryker Sustainability Solutions · Class II · Cleared Mar 8, 2022
| K-number | K211140 |
| Device name | Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (1860 Pediatric O2 Transducer), Reprocessed Masimo Pulse Oximeter (1861 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (1862 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2317 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2319 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (2320 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2328 Infant O2 |
| Applicant | Stryker Sustainability Solutions |
| Product code | DQA |
| Device class | Class II |
| Decision date | Mar 8, 2022 |
| Decision | Substantially Equivalent |
| Regulation | 870.2700 |
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