Product code LIX

Device name

Aid, Cardiopulmonary Resuscitation

Medical specialty

Cardiovascular

Device class

2

Regulation number

870.5210

Review panel

CV

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

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

Source

FDA openFDA device classification dataset