Device Listing 1014675709

Listing Summary#

Listing key
1014675709
Premarket submission
K251463
Device
EnSite™ X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite™ X EP System, AutoMark Index Temporary Software License (ENSITE-D-AMI-01)
Applicant
ABBOTT MEDICAL
Product code
DQK
Decision date
2025-09-04