CCC

15 FDA 510(k) clearances · Product code

FDA profile

Official device name

Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling

Device class

Class II (moderate risk)

Regulation

21 CFR 868.1150

Medical specialty

Anesthesiology

Flags

Third-party review eligible

Adverse events (MAUDE)

1993: 1 · 1996: 6 · 1997: 2 · 1998: 2 · 1999: 2 · 2007: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free