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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device spirometer, diagnostic
Regulation Description Diagnostic spirometer.
Product CodeBZG
Regulation Number 868.1840
Device Class 2


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 1
ALLIED HEALTHCARE PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET
  SUBSTANTIALLY EQUIVALENT 1
DRAEGER MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ENGINEERED MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
FUKUDA DENSHI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
INNOVISION A/S
  SUBSTANTIALLY EQUIVALENT 1
INTEGRATED MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
NELLCOR PURITAN BENNETT
  SUBSTANTIALLY EQUIVALENT 6
PALL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
PULMONX, INC.
  SUBSTANTIALLY EQUIVALENT 2
QRS
  SUBSTANTIALLY EQUIVALENT 2
SALTER LABS
  SUBSTANTIALLY EQUIVALENT 1
SCHILLER
  SUBSTANTIALLY EQUIVALENT 4
SENSORMEDICS
  SUBSTANTIALLY EQUIVALENT 5
SYNECTICS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
UTAH MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VIASYS HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
WELCH ALLYN, INC.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Shock, electrical 1
Foreign material present in device 1
Total Device Problems 2

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