510(k) Report

Devices descending from K093243

2 later devices reach Coagusense Self-Test Prothrombin Time/Inr Monitoring System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183255Coag-Sense Prothrombin Time (PT) / INR Monitoring DeviceCoagusense, Inc.201911
+2K212779Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-TestingCoagusense, Inc.20220—