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Vivatmo pro
Bosch Healthcare Solutions GmbH · Model F09G100510 · UDI-DI 04059233001274
MXA
Prescription
10
510(k) clearances
0
Adverse events
1
Recalls
12
Facilities
Description
Vivatmo pro Nitric Oxide test is a portable, non-invasive device to measure fractional exhaled nitric oxide (FeNO) in human breath.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-02-26 | CAIRE DIAGNOSTICS INC | Erroneously high FeNO levels which may contribute to premature discontinuation of effective asthma treatment and persistent underlying disease. Two issues affecting the FeNO readi |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.
