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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device stethoscope, electronic
Regulation Description Stethoscope.
Product CodeDQD
Regulation Number 870.1875
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 6
BIO-RESEARCH ASSOCIATES, INC.
  SUBSTANTIALLY EQUIVALENT 1
DONGJIN MEDICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
GRAHAM-FIELD HEALTH PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
HEALTH & LIFE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INOVISE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
KORATEK COMPANY, LTD.
  SUBSTANTIALLY EQUIVALENT 1
MINNESOTA MINING AND MFG. CO.
  SUBSTANTIALLY EQUIVALENT 1
PISHON HIGH TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
RNK PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 5
Sharp Corporation
  SUBSTANTIALLY EQUIVALENT 1
TECHTRADE LLC
  SUBSTANTIALLY EQUIVALENT 1
TYTAN MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
ZARGIS MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 5

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