510(k) K162332 ยท FCX Insufflator, Automatic Carbon-Dioxide For Endoscope
Nexcore GI Insufflator
| Applicant | Nexcore Technology, LLC, Winchester MA, US |
| Decision | Substantially Equivalent, Sep 29, 2016 |
| Received | Aug 19, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162332
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.