510(k) K212695 ยท OWN Confocal Optical Imaging
KARL STORZ ICG Imaging System
| Applicant | Karl Storz Endoscopy America, El Segundo CA, US |
| Decision | Substantially Equivalent, Nov 15, 2021 |
| Received | Aug 25, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212695
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.