510(k) Report

Devices descending from K063488

7 later devices reach MAXO2 CU through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122290Envitec Mysign O Oxygen Measuring DeviceEnvitec-Wismar GmbH20133—
+1K072845Precision FlowVapotherm, Inc.200828
+2K254078HVT 2.0Vapotherm, Inc.20260—
+2K183687LifeWindow LW8 LiteDigicare Biomedical Technology, Inc.20191—
+2K133064Mysign S Pulse Oximeter, Mysign PC Software (Optional), Softtip Large R-3211-31, Finger…Envitec-Wismar GmbH20140—
+2K111640Precision Flow (R) - HelioxVapotherm, Inc.201101
+3K200434V20, V20a, AVSM3 SNFMediana Co., Ltd.202001