510(k) K190985 ยท FCX Insufflator, Automatic Carbon-Dioxide For Endoscope
BAROnova Insufflation System, BAROnova Accessory Kit
| Applicant | Baronova, Inc., San Carlos CA, US |
| Decision | Unknown, May 14, 2019 |
| Received | Apr 15, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190985
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.