FDA 510(k)

MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System

K-Number: K230265 · 2023-10-06

Decision Date2023-10-06

Product CodeDSI

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System is a medical device manufactured by Infobionic, Inc.. It received FDA 510(k) clearance on 2023-10-06 under approval number K230265. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System?

MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System is a medical device that received FDA 510(k) clearance on 2023-10-06. It is manufactured by Infobionic, Inc.. The 510(k) number is K230265.

When was MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System approved by the FDA?

MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System received FDA 510(k) clearance on 2023-10-06, under approval number K230265.

What company makes MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System?

MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System is manufactured by Infobionic, Inc..

What is the FDA product code for MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System?

The FDA product code for MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System is DSI.

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Other Devices by Infobionic, Inc.

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Official Source

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