510(k) K231854 ยท OWN Confocal Optical Imaging
1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM
| Applicant | Stryker, San Jose CA, US |
| Decision | Substantially Equivalent, Sep 20, 2023 |
| Received | Jun 23, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231854
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.