510(k) Report

Devices descending from K030849

3 later devices reach Amnisure Fetal Membranes Rupture Test Model FMRT1 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110605Rom PlusClinical Innovations, LLC201101
+1K061886Actim Prom and ControlsMedix Biochemica20072—
+2K123986Actim PromAlere Scarborough, Inc.201401