510(k) K152583 ยท OWN Confocal Optical Imaging
KARL STORZ Endoscopic ICG Imaging System
| Applicant | KARL STORZ Endoscopy-America, Inc., El Segundo CA, US |
| Decision | Substantially Equivalent, May 31, 2016 |
| Received | Sep 10, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152583
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.