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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device tonometer, ac-powered
Regulation Description Tonometer and accessories.
Product CodeHKX
Regulation Number 886.1930
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCUTOME ULTRASOUND, INC.
  SUBSTANTIALLY EQUIVALENT 1
Bio-Rad Laboratories
  SUBSTANTIALLY EQUIVALENT 5
CANON
  SUBSTANTIALLY EQUIVALENT 2
COOPERVISION
  SUBSTANTIALLY EQUIVALENT 2
KOWA CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
LEICA MICROSYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
OCULUS OPTIKGERATE GMBH
  SUBSTANTIALLY EQUIVALENT 1
REICHERT INC.
  SUBSTANTIALLY EQUIVALENT 2
RYAZAN STATE INSTRUMENTS
  SUBSTANTIALLY EQUIVALENT 1
SPAN-AMERICA MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
XOMED, INC.
  SUBSTANTIALLY EQUIVALENT 1

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