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
1244894438
Device Listing 1244894438
Listing Summary
#
Listing key
1244894438
Premarket submission
K173830
Device
MAC VU360 Resting ECG Analysis System
Applicant
Ge Medical Systems Information Technologies, Inc.
Product code
DPS
Decision date
2018-09-18
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
26627
1651104
3002737156
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
1
Y
2026-01-01
465 PAN AMERICAN DR STE 11 EL PASO TX US 79907
26613
2124823
2124823
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
1
Y
2020-04-25
8200 W TOWER AVE Milwaukee WI US 53223
122400
3008729547
3008729547
Tracey Holevas
1
N
2026-01-01
3000 N. Grandview BLVD Waukesha WI US 53188
239256
3012359877
3012359877
GE Medical Systems Information Technologies, Inc.
1
N
2026-01-01
9900 Innovation Drive Wauwatosa WI US 53226