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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stethoscope, electronic
Product CodeDQD
Regulation Number 870.1875
Device Class 2


Premarket Reviews
ManufacturerDecision
AUSCULTHING OY
  SUBSTANTIALLY EQUIVALENT 1
AVICENA LLC
  SUBSTANTIALLY EQUIVALENT 1
CHIP IDEAS ELECTRONICS S.L
  SUBSTANTIALLY EQUIVALENT 2
CHIP IDEAS ELECTRONICS S.L.
  SUBSTANTIALLY EQUIVALENT 3
CSD LABS GMBH
  SUBSTANTIALLY EQUIVALENT 2
EKO DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 3
EKO HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
ENTAC MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
GV CONCEPTS
  SUBSTANTIALLY EQUIVALENT 1
HD MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
HEARTBUDS LLC
  SUBSTANTIALLY EQUIVALENT 1
HEFEI MINTTI MEDICAL TECHNOLOGY CO., LTD. CHINA
  SUBSTANTIALLY EQUIVALENT 1
HEROIC FAITH INTERNATIONAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
HOMEDIAGNOSTIC LLC
  SUBSTANTIALLY EQUIVALENT 1
LAPSI HEALTH HOLDING B.V
  SUBSTANTIALLY EQUIVALENT 1
M3DICINE PTY LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDAICA INC.
  SUBSTANTIALLY EQUIVALENT 1
MYHOMEDOC LTD.
  SUBSTANTIALLY EQUIVALENT 1
NONAGON LTD.
  SUBSTANTIALLY EQUIVALENT 1
SANOLLA LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI HULU DEVICES CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SMARTSOUND CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SONAVI LABS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SOUND LAND CORP.
  SUBSTANTIALLY EQUIVALENT 1
SPARROW ACOUSTICS INC.
  SUBSTANTIALLY EQUIVALENT 2
STRATOSCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1

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