510(k) Report

Devices descending from K112390

8 later devices reach Monica AN24 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153262PUREtrace™Nemo Healthcare BV20170—
+1K142583LaborView LV1000Obmedical Company20151—
+1K140862Monica Novii Wireless Patch SystemMonica Healthcare, Ltd.201432
+1K131889Eum 100PROPromedic, Inc.20140—
+2K233440Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch…Philips Medizin Systeme Boeblingen GmbH20240—
+2K231964Novii+ Wireless Patch SystemDatex Ohmeda20231—
+2K190798LaborView™ LV1000 Wireless Electrode SystemObmedical Company20200—
+3K254036Novii+ Wireless Patch SystemDatex Ohmeda, Inc.20260—