510(k) Report

Devices descending from K150901

2 later devices reach Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 Express through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173042Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models…Edan Instruments, Inc.201812
+2K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.20250—