Skip to content
FDA.report
Public FDA data
NDC
RxNorm
DailyMed
Applications
GUDID
GMDN
PMA
PMN
MAUDE
Recalls
Search FDA.report
Search
Home
Company-Registration
1460133881
Device Listing 1460133881
Listing Summary
#
Listing key
1460133881
Premarket submission
K250356
Device
MoMe ARCĀ® Wireless Ambulatory ECG Monitoring and Detection System (32000)
Applicant
Infobionic, Inc.
Product code
DSI
Decision date
2025-07-29
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
192910
3010112812
3010112812
INFOBIONIC, INC.
1
N
2026-01-01
321 Billerica Rd Office Link #5 Chelmsford MA US 01824