510(k) Report

Devices descending from K041026

4 later devices reach Ambu Blue Sensor, MRX, Ecg Electrode Product #:MRX-00-S through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140862Monica Novii Wireless Patch SystemMonica Healthcare, Ltd.201432
+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—
+3K254036Novii+ Wireless Patch SystemDatex Ohmeda, Inc.20260—