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CoSense ETCO Monitor
Capnia, INC. · Model C20112 · UDI-DI 00858481006017
CCJ
Prescription
3
510(k) clearances
0
Adverse events
1
Recalls
12
Facilities
Description
A reusable electrical medical device with integrated software used in conjunction with a precision sampling set to collect a breath sample from the patient and measure the end tidal carbon monoxide in exhaled breath. The device is non-sterile. No reprocessing is required between uses.
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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