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

Clearance record K230184

Holter ECG and ABP System · Edan Instruments, Inc. · decided 2023-09-25 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
Holter ECG and ABP SystemSA-15Edan Instruments, Inc.DSH DXN06944413820463
Holter ECG and ABP SystemSA-20Edan Instruments, Inc.DSH DXN06944413820500
Holter ECG and ABP SystemSA-16Edan Instruments, Inc.DSH DXN06944413820470
Holter ECG and ABP SystemSA-18Edan Instruments, Inc.DSH DXN06944413820487
Holter ECG and ABP SystemSA-19Edan Instruments, Inc.DSH DXN06944413820494