510(k) Report

Devices descending from K123658

4 later devices reach Biomodule 3-M1 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192875Philips Biosensor BX100Philips Medical Systems20200—
+1K181165Philips wearable biosensor-G5 SolutionConnected Sensing- A Division of Philips Medical Systems20191—
+1K163694Rooti Rx ECG Event Recorder, Rooti Link APP SoftwareRooti Labs, Ltd.20171—
+2K213233EZYPRO ECG Recorder (Model: UG02)Sigknow Biomedical Co., Ltd.20220—