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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
AUSCULTHING OY
  SUBSTANTIALLY EQUIVALENT 1
CHIP IDEAS ELECTRONICS S.L.
  SUBSTANTIALLY EQUIVALENT 2
CSD LABS
  SUBSTANTIALLY EQUIVALENT 1
CSD LABS GMBH
  SUBSTANTIALLY EQUIVALENT 1
EKO DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 2
EKO HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 2
ENTAC MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
GV CONCEPTS
  SUBSTANTIALLY EQUIVALENT 1
HEARTBUDS, LLC
  SUBSTANTIALLY EQUIVALENT 1
HEROIC FAITH INTERNATIONAL , LTD.
  SUBSTANTIALLY EQUIVALENT 2
HOMEDIAGNOSTIC, LLC
  SUBSTANTIALLY EQUIVALENT 1
KNEEVOICE, INC.
  SUBSTANTIALLY EQUIVALENT 1
LAPSI HEALTH HOLDING B.V.
  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
SOUND LAND CORP.
  SUBSTANTIALLY EQUIVALENT 1
SPARROW ACOUSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 4
STRATOSCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Temperature Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Skin Burning Sensation 1 1

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