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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device auxillary power supply (ac or dc) for external transcutaneous cardiac pacemaker
Regulation Description External transcutaneous cardiac pacemaker (noninvasive).
Product CodeMPE
Regulation Number 870.5550
Device Class 2


Premarket Reviews
ManufacturerDecision
PHYSIO-CONTROL, INC.
  SUBSTANTIALLY EQUIVALENT 1

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