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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
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 1
ACTIVE SIGNAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
AMERICAN DIAGNOSTIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
AUM CARDIOVASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
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
DIACOUSTIC MEDICAL (PTY)
  SUBSTANTIALLY EQUIVALENT 1
DIACOUSTIC MEDICAL DEVICES (PTY) LTD.
  SUBSTANTIALLY EQUIVALENT 2
EKO DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 5
  1.  K151319  Eko Electronic Stethoscope System
  2.  K170874  Eko Model E5 System (EME5), Eko DUO
  3.  K200776  Eko CORE
  4.  K213794  Eko Murmur Analysis Software (EMAS)
  5.  K230111  CORE 500 Digital Stethoscope
EKO HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
ENTAC MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
GI LOGIC INC
  SUBSTANTIALLY EQUIVALENT 1
GV CONCEPTS
  SUBSTANTIALLY EQUIVALENT 1
HD MEDICAL SERVICES (INDIA) PVT.LTD
  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
IMEDIPLUS INC.
  SUBSTANTIALLY EQUIVALENT 2
IMEDIPLUS, INC.
  SUBSTANTIALLY EQUIVALENT 1
INOVISE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
LAPSI HEALTH HOLDING B.V
  SUBSTANTIALLY EQUIVALENT 1
M3DICINE PTY LTD.
  SUBSTANTIALLY EQUIVALENT 1
M3DICINE PTY. LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDAICA INC.
  SUBSTANTIALLY EQUIVALENT 1
MYHOMEDOC LTD.
  SUBSTANTIALLY EQUIVALENT 1
NOBLE ANESTHESIA-AIR, INC.
  SUBSTANTIALLY EQUIVALENT 1
NONAGON LTD.
  SUBSTANTIALLY EQUIVALENT 1
PARACE LLC
  SUBSTANTIALLY EQUIVALENT 1
PROTRON TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
RIJUVEN CORP
  SUBSTANTIALLY EQUIVALENT 1
RNK PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 3
SANOLLA LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI HULU DEVICES CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHARP CORPORATION
  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
STETHOCLOUD PTY.LTD (CLINICLOUD)
  SUBSTANTIALLY EQUIVALENT 1
STETHOSCOPE TECHNOLOGIES, INC
  SUBSTANTIALLY EQUIVALENT 1
STRATOSCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
STRATOSCIENTIFIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
TYTO CARE LTD.
  SUBSTANTIALLY EQUIVALENT 2
ZARGIS MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 2

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