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System, Test, Breath Nitric Oxide

FDA product code MXA · Class 2 · Clinical Toxicology

38
Registered devices
0
Adverse events
1
Recalls
15
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2021-02-26CAIRE DIAGNOSTICS INCErroneously high FeNO levels which may contribute to premature discontinuation of effective asthma treatment and persistent underlying disease. Two issues affe

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.