510(k) Report

Devices descending from K090285

4 later devices reach Sonicaid FM820 and FM830 Encore through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200975Sonicaid Team3 Antepartum, Sonicaid Team3 IntrapartumHuntleigh Healthcare Limited20203—
+2K241368Sonicaid Team3Huntleigh Healthcare, Ltd.20252—
+3K250777Sonicaid Team3Huntleigh Healthcare, Ltd.20251—
+4K253021ANNE MaternalSibel Health, Inc.20260—