510(k) Report

Devices descending from K180234

7 later devices reach physiQ Heart Rhythm Module through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192004Eko Analysis SoftwareEko Devices, Inc.20204—
+1K183322physIQ Heart Rhythm and Respiratory ModulePhysiq, Inc.20191—
+2K213794Eko Murmur Analysis Software (EMAS)Eko Devices, Inc.20223—
+2K193415physIQ Heart Rhythm and Respiration ModulePhysiq, Inc.20200—
+3K251494Eko Foundation Analysis Software with Transformers (EFAST)Eko Health, Inc.20250—
+3K240901StethophoneSparrow Acoustics, Inc.20241—
+4K252595Stethophone ProSparrow Acoustics, Inc.20250—