510(k) Report

Devices descending from K980876

15 later devices reach Asthma Monitor AM2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090486Asthma Monitor Model, AM1Cardinal Health Germany 234 GmbH200914—
+2K092890Asthma Monitor AM3Carefusion Germany 234 GmbH20103—
+2K092324SpiroproViasys Healthcare GmbH20099—
+3K142959Vyntus WalkCarefusion Germany 234 GmbH20150—
+3K141936Microblab, MicroloopCarefusion Germany 234 GmbH20140—
+3K133722Asthma Monitor AM3Eresearch Technology20142—
+3K100687Vitalograph Hand Held Spirometer, Model 2120Vitalograph (Ireland), Ltd.20106—
+4K200550Vitalograph Model 2120 In2itive eDiaryVitalograph Ireland, Ltd.20202—
+4K183479Asthma Monitor AM3Eresearch Technology20190—
+4K183586CapMedicCognita Labs, LLC20190—
+4K160253Vitalograph Model 6300 microVitalograph (Ireland), Ltd.20160—
+4K142642Vitalograph Model 6600 CompactVitalograph (Ireland), Ltd.20150—
+4K142812Vitalograph Model 6800 PneumotracVitalograph (Ireland), Ltd.20151—
+5K212938Vitalograph Model 6000 AlphaVitalograph Ireland, Ltd.20221—
+6K251777MESI mTABLET SPIROMesi D.O.O.20260—