510(k) Report

Devices descending from K002548

6 later devices reach Fetal Assist through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K020390Modification to Fetal AssistHuntleigh Diagnostics, Ltd.20025—
+2K143114Sense4Baby System Model B+ (MSA)Airstrip Technologies, Inc.201541
+3K253673M•care System (MW-20)Marani Health, Inc.20260—
+3K210025INVU by NuvoNuvo- Group, Ltd.20211—
+3K191401PregSenseNuvo- Group, Ltd.20200—
+4K221046Invu by NuvoNuvo- Group, Ltd.20220—