510(k) K152160 ยท DQK Computer, Diagnostic, Programmable
Navik 3D
| Applicant | Apn Health, LLC, Pleasanton CA, US |
| Decision | Substantially Equivalent, Feb 23, 2016 |
| Received | Aug 3, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152160
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 14, 2023 | APN Health LLC Navik 3D v2, REF NAVIK3D, 3D Mapping System Open, Classified |
DQK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.