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U.S. Department of Health and Human Services

Product Classification

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Device aid, cardiopulmonary resuscitation
Regulation Description Cardiopulmonary resuscitation (CPR) aid.
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.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeLIX
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Circulatory Support Devices Branch (CSDB)
Submission Type 510(k)
Regulation Number 870.5210
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible