510(k) Report

Devices descending from K000625

4 later devices reach Scandinavian Ivf Sciences AB, G1.2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K030490ISM1+, IMS2+, and Utm+Medicult A/S20033—
+2K080473Embryoassist and Embryoassist with Phenol RedMedicult A/S20082—
+3K120136EmbryogenOrigio A/S20121—
+4K140317EmbryogenOrigio A/S20140—