510(k) Report

Devices descending from K073545

11 later devices reach Audicor, Hemo Ambulatory Monitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192004Eko Analysis SoftwareEko Devices, Inc.20204—
+1K173156Integrated CardioRespiratory SystemSensydia, Inc.20180—
+1K110569Audicor Cpam (Cardiopulmonary Ambulatory Monitor)Inovise Medical, Inc.20114—
+2K213794Eko Murmur Analysis Software (EMAS)Eko Devices, Inc.20223—
+2K120462Audicor Cpam with SDB (Cardiopulmonary Ambulatory Monitor with Sleep Disordered…Inovise Medical, Inc.20123—
+3K251494Eko Foundation Analysis Software with Transformers (EFAST)Eko Health, Inc.20250—
+3K240901StethophoneSparrow Acoustics, Inc.20241—
+3K131883Audicor Cpam with SDB (Accelerometer Based)Inovise Medical, Inc.20141—
+3K130660Audicor Cpam with SDB (Single Sensor)Inovise Medical, Inc.20130—
+4K252595Stethophone ProSparrow Acoustics, Inc.20250—
+4K151433AUDICOR CA300/CC100 Analyzer with SDBInovise Medical, Inc.20160—