510(k) Report

Devices descending from K992164

23 later devices reach Telemedicine 2000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K024365TM2005 Personal Medical Phone CenterCard Guard Scientific Survival, Ltd.200319—
+1K013879TM2000, Model 1Card Guard Scientific Survival, Ltd.20021—
+1K013175TM2000 Easytrace Plus Receiving CenterCard Guard Scientific Survival, Ltd.20010—
+2K050940PMP4 Medical Web CenterCard Guard Scientific Survival, Ltd.200518—
+2K021574TM2000 Fetaltrace Transtelephonic Receiving CenterCard Guard Scientific Survival, Ltd.20020—
+3K131699Emotion Ecg MobileMega Electronics, Ltd.201316—
+3K060703PMP4 BP Pro Blood Pressure MonitorCard Guard Scientific Survival, Ltd.20060—
+4K143032eMotion Faros ECG MobileMega Electronics, Ltd.20156—
+4K141813Rhythmstar SystemRhythMedix, LLC20148—
+5K233584RhythmStar SystemRhythMedix, LLC20241—
+5K183704RX-1 Rhythm Express Remote Cardiac Monitoring SystemVivaQuant, Inc.20192—
+5K172311BioFlux DeviceBiotricity, Inc.20171—
+5K172801ECG SENTINEL SystemCardiomedix, Inc.20170—
+5K161431SimplECGNanowear, Inc.20165—
+6K250793RhythmStar System (SL)RhythMedix, LLC20260—
+6K233864ASSURE Wearable ECGKestra Medical Technologies, Inc.20240—
+6K201669SimpleSENSENanowear, Inc.20203—
+6K200833RX-1 Rhythm Express Remote Cardiac Monitoring SystemVivaQuant, Inc.20201—
+6K173248CardioskinBioserenity Sas20180—
+7K243981Hexoskin Medical System (7100-00016)Carre Technologies, Inc.20250—
+7K241179Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)VivaQuant, Inc.20250—
+7K212160SimpleSENSE PlatformNanowear, Inc.20211—
+8K232053SimpleSense-BP, SimpleSense-BP Software ApplicationNanowear, Inc.20230—