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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device adjunct monitor, protein calorie malnutrition
Regulation Description Impedance plethysmograph.
Definition Device applies an alternating current of one specified frequency or more through skin-surface electrodes to estimate one or more the body composition parameters.
Product CodeQJB
Regulation Number 870.2770
Device Class 2


Premarket Reviews
ManufacturerDecision
IMPEDIMED LIMITED
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2024 1 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1 2

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