510(k) Report

Devices descending from K193310

6 later devices reach myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202876Confirm Rx Insertable Cardiac MonitorAbbott (St. Jude Medical)20200—
+1K202888Confirm Rx Insertable Cardiac MonitorAbbott (St. Jude Medical)20204—
+2K212206Jot Dx Insertable Cardiac MonitorAbbott (St. Jude Medical)20213—
+3K230286Assert-IQ™ Insertable Cardiac MonitorAbbott Medical20232—
+4K251221Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000)Abbott20251—
+5K253516Assert-IQ (DM5100)Abbott Medical20250—