510(k) Report

Devices descending from K162580

2 later devices reach Guardian Angel GA1000 Digital Vital Sign Monitoring System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233963Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)Taiwan Aulisa Medical Devices Technologies, Inc.20250—
+1K200537OxxiomTrue Wearables, Inc.20200—