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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K231104

ABPMpro · Somnomedics GmbH · decided 2023-11-27 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
ABPM pro basic deviceABP050USOMNOmedics AGDSH DXN04250413405640
Cuff ABPMpro for right armABP501RSOMNOmedics AGDSH DXN04250413406463
Cuff ABPMpro without ECGABP502/BSOMNOmedics AGDSH DXN04250413403585
Cuff ABPMpro without ECGABP501/BSOMNOmedics AGDSH DXN04250413403578
Cuff ABPMpro for right armABP500RSOMNOmedics AGDSH DXN04250413406456
ABPMpro cuff for right armABP502RSOMNOmedics AGDSH DXS04250413406470
PlethRing sensor Large (21mm)ABP510/LSOMNOmedics AGDSH DXN04250413405909
PlethRing sensor Medium (19mm)ABP510/MSOMNOmedics AGDSH DXN04250413405893
PlethRing sensor Small (17mm)ABP510/SSOMNOmedics AGDSH DXN04250413405886
PlethRing Sensor X-Large (23mm)ABP510/XLSOMNOmedics AGDSH DXN04250413405916
Cuff ABPMpro without ECGABP500/BSOMNOmedics AGDSH DXN04250413403561
External ECG sensor for ABPMproABP520SOMNOmedics AGDSH DXN04250413402991