510(k) K192174 ยท OWN Confocal Optical Imaging
SPY Portable Handheld Imaging (SPY-PHI) System
| Applicant | Novadaq Technologies Ulc. (Now A Part of Stryker), Burnaby, CA |
| Decision | Substantially Equivalent, Nov 15, 2019 |
| Received | Aug 12, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192174
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.