Infobionic Inc

FDA Filings

This page includes the latest FDA filings for Infobionic Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3010112812
FEI Number3010112812
NameINFOBIONIC, INC.
Owner & OperatorInfoBionic, Inc.
Contact Address200 5th Ave 4030
Waltham MA 02451 US
Official Correspondent
  • Dave MacCutcheon
  • 001-978-6748304-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address200 5th Ave 4030
Waltham, MA 02451 US
Establishment TypeComplaint File Establishment per 21 CFR 820.198

FDA Filings

Device
Company
DeviceDate
Infobionic, Inc.
 MoMe® ARC 2025-09-02
Infobionic, Inc.
 MoMe® ARC 2024-01-05
INFOBIONIC, INC.
 MoMe® Kardia 2019-05-07
INFOBIONIC, INC.
 MoMe® Software Platform 2018-10-24
INFOBIONIC, INC.
MoMe Kardia2016-03-31
INFOBIONIC, INC.
MoMe Software Platform2016-03-31
INFOBIONIC, INC.
MoMe Kardia Wireless Ambulatory ECG Monitoring And Detection System2016-03-11
INFOBIONIC, INC.
MoMe Software Platform2015-12-17
INFOBIONIC, INC.
MOME ECG CONTINUOUS DETECTION AND ARRHYTHMIA DETECTOR2014-09-19

Related Finance Registrations
NCAGE Code6TG71INFOBIONIC, INC.
CAGE Code6TG71INFOBIONIC, INC.
S.A.M. Registration6TG71 [78650138]INFOBIONIC, INC.
SEC0001562779InfoBionic, Inc. of DELAWARE
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