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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, test, breath nitric oxide
Product CodeMXA
Regulation Number 862.3080
Device Class 2


Premarket Reviews
ManufacturerDecision
AEROCRINE AB
  SUBSTANTIALLY EQUIVALENT 4
APIERON, INC.
  SUBSTANTIALLY EQUIVALENT 1
BEDFONT SCIENTIFIC LTD
  SUBSTANTIALLY EQUIVALENT 1
BOSCH HEALTHCARE SOLUTIONS GMBH
  SUBSTANTIALLY EQUIVALENT 1
CAIRE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1
CIRCASSIA AB
  SUBSTANTIALLY EQUIVALENT 1
SPIROSURE, INC.
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 CAIRE DIAGNOSTICS INC II Mar-19-2021
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