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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device recorder, magnetic tape, medical
Regulation Description Medical magnetic tape recorder.
Product CodeDSH
Regulation Number 870.2800
Device Class 2


Premarket Reviews
ManufacturerDecision
AGILENT TECHNIOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
CARD GUARD SCIENTIFIC SURVIVAL, LTD.
  SUBSTANTIALLY EQUIVALENT 3
CARDIAC SCIENCE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
DIAGNOSTIC MONITORING SOFTWARE
  SUBSTANTIALLY EQUIVALENT 1
HEWLETT-PACKARD CO.
  SUBSTANTIALLY EQUIVALENT 1
INTERNATIONAL MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
IRHYTHM TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 4
MARQUETTE
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
MORTARA
  SUBSTANTIALLY EQUIVALENT 2
NORTHEAST MONITORING, INC.
  SUBSTANTIALLY EQUIVALENT 2
PFIZER
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
PHYSIO-CONTROL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ROZINN ELECTRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
SCHILLER
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN CREATIVE INDUSTRY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS
  SUBSTANTIALLY EQUIVALENT 1
VASOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
VIASYS HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Circuit Failure 2
Electrical issue 2
Use of Device Issue 2
Improper or incorrect procedure or method 1
Device displays error message 1
Device operates differently than expected 1
Temperature issue 1
No code available 1
Mislabeled 1
Inappropriate shock 1
Component(s), overheating of 1
Burn of device or device component 1
Total Device Problems 15

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