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Infobionic, Inc. FDA Approvals

0 new drug approvals and 2 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product
MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)510(k)Jul 29, 2025Cardiovascular
MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System510(k)Oct 6, 2023Cardiovascular

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