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NIOX
Circassia AB · Model Apps / Panel · UDI-DI 07350047030519
MXA
Prescription
1
510(k) clearances
0
Adverse events
1
Recalls
12
Facilities
Description
NIOX Apps / Panel is an optional software accessory allowing an additional display for the NIOX serise of Airway Inflammation Monitors including the NIOX MINO 09 and NIOX VERO devices.
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.
