TPLC - Total Product Life Cycle

• Device: stethoscope, electronic
• Regulation Description: Stethoscope.
• Product Code: DQD
• Regulation Number: 870.1875
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
AI HEALTH HIGHWAY INDIA PVT., LTD.
	SUBSTANTIALLY EQUIVALENT	1
AUSCULTHING OY
	SUBSTANTIALLY EQUIVALENT	1
CHIP IDEAS ELECTRONICS S.L.
	SUBSTANTIALLY EQUIVALENT	4
CSD LABS
	SUBSTANTIALLY EQUIVALENT	1
CSD LABS GMBH
	SUBSTANTIALLY EQUIVALENT	1
EKO DEVICES, INC.
	SUBSTANTIALLY EQUIVALENT	3
EKO HEALTH, INC.
	SUBSTANTIALLY EQUIVALENT	3
ENTAC MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
GV CONCEPTS
	SUBSTANTIALLY EQUIVALENT	1
HD MEDICAL, INC.
	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
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	2
SMARTSOUND CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
SONAVI LABS, INC.
	SUBSTANTIALLY EQUIVALENT	1
SOUND LAND CORP.
	SUBSTANTIALLY EQUIVALENT	1
SPARROW ACOUSTICS, INC.
	SUBSTANTIALLY EQUIVALENT	4
STRATOSCIENTIFIC
	SUBSTANTIALLY EQUIVALENT	1
TYTO CARE , LTD.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2024	1	1
2026	1	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Temperature Problem	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Skin Burning Sensation	2	2