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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device abnormal breath sound device
Regulation Description Diagnostic pulmonary-function interpretation calculator.
Definition The device is intended to measure abnormal breath sound, such as wheeze, rhonchi, and whistling.
Product CodePHZ
Regulation Number 868.1900
Device Class 2


Premarket Reviews
ManufacturerDecision
RESPIRI LIMITED
  SUBSTANTIALLY EQUIVALENT 1
TYTO CARE , LTD.
  SUBSTANTIALLY EQUIVALENT 4

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