Aid, Cardiopulmonary Resuscitation

LIX · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.5210

Classification

FDA Product Code: LIX
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 870.5210
Review panel: CV
Medical specialty: Cardiovascular
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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

Market data

Cleared 510(k) submissions: 17
Registered establishments: 17

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown