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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device plethysmograph, impedance
Regulation Description Impedance plethysmograph.
Product CodeDSB
Regulation Number 870.2770
Device Class 2


Premarket Reviews
ManufacturerDecision
ECOM MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
IMPEDIMED LIMITED
  SUBSTANTIALLY EQUIVALENT 3
PHYSIOWAVE, INC.
  SUBSTANTIALLY EQUIVALENT 1
SENSIBLE MEDICAL INNOVATIONS LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZYNEX MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Resultor Readings 1 1
Device Operates Differently Than Expected 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 1 1
No Known Impact Or Consequence To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Partners In Medicine Llc II Jan-04-2016
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