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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device condenser, heat and moisture (artificial nose)
Regulation Description Heat and moisture condenser (artificial nose).
Product CodeBYD
Regulation Number 868.5375
Device Class 1


Premarket Reviews
ManufacturerDecision
BIRD PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
GAMBRO
  SUBSTANTIALLY EQUIVALENT 1
HELIX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ICOR
  SUBSTANTIALLY EQUIVALENT 9
KING SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
MALLINCKRODT
  SUBSTANTIALLY EQUIVALENT 5
PALL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
PORTEX, INC.
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS
  SUBSTANTIALLY EQUIVALENT 2
VITAL SIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Detachment of device component 2
Other (for use when an appropriate device code cannot be identified) 1
Unknown (for use when the device problem is not known) 1
Obstruction within device 1
Moisture or humidity problem 1
Blockage within device or device component 1
Total Device Problems 7

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 1 0 0
Class II 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Vital Signs Devices, a GE Healthcare Company I Jul-30-2011

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