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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device aid, cardiopulmonary resuscitation
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
Product CodeLIX
Regulation Number 870.5210
Device Class 2


Premarket Reviews
ManufacturerDecision
BIO-DETEK, INC.
  SUBSTANTIALLY EQUIVALENT 1
LAERDAL MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 2
PHYSIO-CONTROL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZOLL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device operates differently than expected 1
Total Device Problems 1

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