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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device humidifier, respiratory, mask (direct patient interface)
Regulation Description Respiratory gas humidifier.
Definition Intended to moderate blood pressure in hypertensive patients when they are exposed to the cold. The mask attenuates (moderates) the physiological response, increases in blood pressure, associated with cold exposure, by warming the inhaled air during cold exposure for individuals with hypertension, medicated or non-medicated.
Product CodeOBN
Regulation Number 868.5450
Device Class 2


Premarket Reviews
ManufacturerDecision
POLAR
  SUBSTANTIALLY EQUIVALENT 1

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