LIX

17 FDA 510(k) clearances · Product code

FDA profile

Official device name

Aid, Cardiopulmonary Resuscitation

Device class

Class II (moderate risk)

Regulation

21 CFR 870.5210

Medical specialty

Cardiovascular

FDA definition

CPR Aid device WITH feedback (visual, audio or both) on one or more CPR parameters (e.g., rate, depth, ventilation ratio, etc.), and contains software. Provides real-time feedback on CPR performance. Feedback can be audio, visual or both. Device contains software

Adverse events (MAUDE)

1993: 1 · 2012: 9 · 2013: 50 · 2014: 55
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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