Infobionic, Inc. - FDA 510(k) Cleared Devices
5
Total
5
Cleared
0
Denied
Infobionic, Inc. has 5 FDA 510(k) cleared medical devices. Based in Lowell, US.
Latest FDA clearance: Jul 2025. Active since 2014. Primary specialty: Cardiovascular.
Browse the FDA 510(k) cleared devices submitted by Infobionic, Inc. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by MethodSense, Inc. as regulatory consultant.
5 devices
Cleared
Jul 29, 2025
MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)
Cardiovascular
172d
Cleared
Oct 06, 2023
MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System
Cardiovascular
248d
Cleared
Mar 11, 2016
MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System
Cardiovascular
58d
Cleared
Dec 17, 2015
MoMe Software Platform
Cardiovascular
107d
Cleared
Sep 19, 2014
MOME ECG CONTINUOUS DETECTION AND ARRHYTHMIA DETECTOR
Cardiovascular
284d