510(k) Report

Devices descending from K983643

6 later devices reach Genesis BLS through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K991195Carevent BLS, Carevent BLS+, Carevent Als, Carevent Als+, and Carevent AtvO-Two Systems Intl., Inc.19995—
+2K113687Equinox RelieveO-Two Medical Technologies, Inc.201212
+2K081330Carevent Par (Public Access Resuscitator)O-Two Medical Technologies, Inc.20092—
+3K173205Equinox AdvantageO-Two Medical Technologies, Inc.20180—
+3K141595O-Two E700,O-Two E600,O-Two E500O-Two Medical Technologies, Inc.20151Class I
+4K221634Oxymag - Transport and Emergency VentilatorMagnamed Tecnologia Medica S/A20230—