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NIOX

Circassia AB · Model MINO Sensor 1000 · UDI-DI 07350047030106

MXA Prescription
1
510(k) clearances
0
Adverse events
1
Recalls
12
Facilities

Description

The NO sensor for NIOX MINO utilizes analytical electrochemical sensor technology. The NO sensor is pre-programmable for a defined number of tests: 50，100，300，500 or 1000 tests.

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 affecting the FeNO readi

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Data 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.