CCJClass II

Analyzer, Gas, Carbon-monoxide, Gaseous-phase

Anesthesiology · 21 CFR 868.1430

MDR events0All time

Recalls1All time

Registered firms19Currently listed

510(k) clearances28All time

Recent MDR events

0 adverse event reports on file

No MDR events on file for this product code.

Event type breakdown

No data available.

Most-reported manufacturers

No data available.

Recalls

1 recall events for this product code

Capnia Inc
Open, ClassifiedJul 29, 2025
Precision Sampling Set, REF: C20206 for use with the CoSense End-Tidal Carbon Monoxide Monitor
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 of the cannula's carbon filter prior to sealing, which may lead to higher than expected ETOCc scores during clinical evaluations.
Z-2198-2025 · View FDA record ↗

Registered firms

19 firms currently registered for this product code

510(k) clearances

28 clearances for this product code