INFOBIONIC, INC.

Address:400 Totten Pond Rd,Waltham,MA,02451,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Detector And Alarm, Arrhythmia (DSI) (2)

Premarket Exempt

Clear

MoMe® Kardia - B690MK10 Catalog Number :

Device Description : MoMe® Kardia is a wireless, remote monitoring system designed to aid physicians MoMe® Kardia is a wireless, remote monitoring system designed to aid physicians in their diagnosis of cardiac arrhythmias in patients with a demonstrated need for cardiac monitoring. MoMe® Kardia includes the wearable device that acquires and stores ECG data and transmits that data via cellular technology to the MoMe® Software Platform, a web-based remote server software with proprietary algorithms for analysis. MoMe® Software Platform analyzes the data via the embedded algorithm and when indicated, data identified by the algorithm is flagged for physician review.

Device Class : 2

Duns Number: 078650138

Premarket Exempt : No

Product Code : DSI

Prescription Use : Yes

Device Count : 1

MoMe® Software Platform - B690MS10 Catalog Number :

Device Description : MoMe® Software Platform is a web-based remote server software with proprietary a MoMe® Software Platform is a web-based remote server software with proprietary algorithms for analysis of ECG data. It analyzes the data via the embedded algorithm and when indicated, data identified by the algorithm is flagged for physician review. The data is sent to the Software Platform from the MoMe® Kardia , a wireless, remote monitoring system designed to aid physicians in their diagnosis of cardiac arrhythmias in patients with a demonstrated need for cardiac monitoring.