M55 K KARAYA GUM DISP. MICROTAPE ECG ELECTRODE, 55

FDA 510(k)

FDA Class 2 ·Cardiovascular

TYPE 9140 (SYSTEM ATHENA)

FDA 510(k)

FDA Class 2 ·Cardiovascular

TYPE 9266 SAO2 SYSTEM ATHENA

FDA 510(k)

FDA Class 2 ·Cardiovascular

9293/1 INTERFACE MODULE

FDA 510(k)

FDA Class 2 ·Cardiovascular

MOD. TYPE 9230 TEMP 1 AND TEMP 2 SYSTEM ATHENA

FDA 510(k)

FDA Class 2 ·General Hospital

TYPE 9292 INTERFACE CAPNOGRAPH

FDA 510(k)

FDA Class 2 ·Anesthesiology

TYPE 9040/NEO

FDA 510(k)

FDA Class 2 ·Cardiovascular

CALIBRATION KIT

FDA 510(k)

FDA Class 1 ·Anesthesiology

AMENDMENT ULTRASOUND SCANNER TYPE 1842/1846/1849

FDA 510(k)

FDA Class 2 ·Radiology

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera MRI DF-1 ICD; Evera MRI ICD; Evera S DR ICD; Evera S VR ICD; Evera XT DR ICD; Evera XT VR ICD; Visia AF MRI DF1 IC

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Visia AF MRI DF1 IC

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Visia AF MRI DF1 IC

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera MRI DF-1 ICD; Evera MRI DF-1 ICD; Evera MRI ICD; Evera MRI ICD; Evera S DR ICD; Evera S VR ICD; Evera XT VR ICD; M

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera MRI DF-1 ICD/ Evera MRI ICD/Evera S DR ICD/ Evera S VR ICD/ Evera XT DR ICD/Evera XT VR ICD/ Visia AF MRI DF1 ICD/

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EVERA MRI DF-1 ICD, EVERA MRI IDC, EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD, VISIA AF MRI DF1 IC

DFS-Diamon GmbH

Importer

🇩🇪 Germany

HX 2028254-1

Certificate

IVDR QMS·DFI Co.,Ltd.·TÜV Rheinland LGA Products GmbH

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR/ S VR ICD, Evera XT DR/ XT VR ICD, Primo MRI DR/VR ICD, Visia AF MRI DF1 I

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera MRI DF-1, MRI, S DR, S VR, XT DR, XT VR, Mirro MRI DR, MRI VR, Primo MRI DR, MRI VR, Visia AF MRI DF1, AF MRI VR,

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·KAINOX VCS,DF1-C6HV,AND VARIOUS MODELS OF LINOX,EFH, AND PROTEGO LEADS