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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cleaner, air, medical recirculating
Product CodeFRF
Regulation Number 880.5045
Device Class 2


Premarket Reviews
ManufacturerDecision
AIR INNOVATIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
AIRSONETT, AB
  SUBSTANTIALLY EQUIVALENT 1
BEIANG AIR TECH LTD.
  SUBSTANTIALLY EQUIVALENT 1
CERROZONE
  SUBSTANTIALLY EQUIVALENT 1
MEDIFY AIR LLC
  SUBSTANTIALLY EQUIVALENT 1
NOVAERUS US INC
  SUBSTANTIALLY EQUIVALENT 1
RIA TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
WINIX INC.
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 Healthway Home Products, Inc. II Jan-31-2012
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