510(k) Report

Devices descending from K943678

21 later devices reach Electronic Flow Meter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K982995Accutrax, Model EPF840Korr Medical Technologies, Inc.199820—
+2K040723Microlife Electronic Peak Flow Monitor, with Pef and FEV1, Models PF-100 and PF-100-1…Microlife Intellectual Property GmbH20049—
+2K031024Microlife Electronic Peak Flow Monitor, Model PF-100Microlife Corp.200310—
+2K022276KokomateFerraris Respiratory, Inc.20028—
+3K253180Microlife Digital Peak Flow Meter, Model PF200B (PF200B)Microlife Corporation20260—
+3K181666Smart OneMir Medical International Research20183—
+3K152276Wing Smart FEVI and Peak Flow MeterSparo, Inc.20164—
+3K092335Peak Expiratory Flow Meter, KN-9710K-Jump Health Co., Ltd.20100—
+3K051572Koko LegendPulmonary Data Services, Inc.20057—
+4K201635MouthLab Vital Signs Monitoring SystemMultisensor Diagnostics (Dba Aidar Health)20210—
+4K200832Safey Peak Flow MeterSafey Medical Devices Pvt, Ltd.20200—
+4K193311AlunaKnox Medical Diagnostics, Inc.20201—
+4K180487Peak.meBreathe Me, Ltd.20180—
+4K100687Vitalograph Hand Held Spirometer, Model 2120Vitalograph (Ireland), Ltd.20106—
+5K232588Aluna 2Knox Medical Diagnostics20240—
+5K200550Vitalograph Model 2120 In2itive eDiaryVitalograph Ireland, Ltd.20202—
+5K160253Vitalograph Model 6300 microVitalograph (Ireland), Ltd.20160—
+5K142642Vitalograph Model 6600 CompactVitalograph (Ireland), Ltd.20150—
+5K142812Vitalograph Model 6800 PneumotracVitalograph (Ireland), Ltd.20151—
+6K212938Vitalograph Model 6000 AlphaVitalograph Ireland, Ltd.20221—
+7K251777MESI mTABLET SPIROMesi D.O.O.20260—