Class Class II

EnSite™ X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite™ X EP System, AutoMark Index Temporary Software License (ENSITE-D-AMI-01) (K251463)

K251463 2025-09-04 Special
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Description

EnSite™ X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite™ X EP System, AutoMark Index Temporary Software License (ENSITE-D-AMI-01) by Abbott Medical, an FDA 510(k) cleared cardiovascular device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK251463
Clearance Date2025-09-04
Clearance TypeSpecial
Product CodeDQK
Regulation Number870.1425

Categories

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