Medical Device Manufacturer · US , Lowell , MA

Infobionic, Inc.

5 submissions · 5 cleared · Since 2014

Total

Cleared

Denied

Infobionic, Inc. — FDA 510(k) Submissions

Infobionic, Inc. has submitted 5 FDA 510(k) premarket notifications since 2014, of which 5 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Detector And Alarm, Arrhythmia, Outpatient Cardiac Telemetry . Use the specialty filter in the sidebar to narrow results.

5 devices

1–5 of 5

MoMe ARC? Wireless Ambulatory ECG Monitoring and Detection System (32000)

K250356 · DSI Detector And Alarm,... · Cardiovascular

Jul 2025 172d

MoMe? ARC Wireless Ambulatory ECG Monitoring and Detection System

K230265 · DSI Detector And Alarm,... · Cardiovascular

Oct 2023 248d

MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System

K160064 · QYX Outpatient Cardiac Telemetry · Cardiovascular

Mar 2016 58d

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