510(k) K182874 ยท MXA System, Test, Breath Nitric Oxide
Fenom Pro Nitric Oxide Test
| Applicant | Spirosure, Inc., Pleasanton CA, US |
| Decision | Substantially Equivalent, Feb 13, 2019 |
| Received | Oct 12, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182874
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 26, 2021 | CAIRE DIAGNOSTICS INC CAIRE DIAGNOSTICS FenomPro REF 900-0001 SN ***** - Product Usage: a portable, non-invasive device to measure fractional exhaled nitric oxide (FeNO) in human breath. Fenom Pro should not be used in cri Terminated |
MXA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.