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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device transmitters and receivers, electrocardiograph, telephone
Regulation Description Telephone electrocardiograph transmitter and receiver.
Product CodeDXH
Regulation Number 870.2920
Device Class 2


Premarket Reviews
ManufacturerDecision
ALIVECOR, INC.
  SUBSTANTIALLY EQUIVALENT 4
CARDIOCOMM SOLUTIONS, INC
  SUBSTANTIALLY EQUIVALENT 1
MEGA ELECTRONICS LTD.
  SUBSTANTIALLY EQUIVALENT 1
VERILY LIFE SCIENCES LLC
  SUBSTANTIALLY EQUIVALENT 2
VITASYSTEMS GMBH
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Failure to Fire 1
Total Device Problems 1

Recalls
Manufacturer Recall Class Date Posted
1 Alivecor SFO III Feb-18-2015
2 Spacelabs Healthcare Inc II Oct-30-2015

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