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iCO Quit Smokerlyzer
BEDFONT SCIENTIFIC LIMITED · Model iCO Quit · UDI-DI 05060246860429
1
510(k) clearances
0
Adverse events
1
Recalls
12
Facilities
Description
The iCOquit breath carbon monoxide (CO) monitor is intended for single person use by individuals wanting to measure the amount of CO on their breath in the home environment, as a motivational aid to help them in their attempt to stop smoking. The iCOquit can also be used by healthcare professionals with individuals in smoking cessation programmes and research.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-04-21 | Capnia Inc | Sampling set nasal cannula used with End-Tidal Carbon Monoxide (ETCO) monitor may have residual carbon monoxide and volatile organic compounds present due to insufficient aeration |
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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.