510(k) Report

Devices descending from K031515

10 later devices reach Spiropro SPO2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092324SpiroproViasys Healthcare GmbH20099—
+2K142959Vyntus WalkCarefusion Germany 234 GmbH20150—
+2K141936Microblab, MicroloopCarefusion Germany 234 GmbH20140—
+2K100687Vitalograph Hand Held Spirometer, Model 2120Vitalograph (Ireland), Ltd.20106—
+3K200550Vitalograph Model 2120 In2itive eDiaryVitalograph Ireland, Ltd.20202—
+3K160253Vitalograph Model 6300 microVitalograph (Ireland), Ltd.20160—
+3K142642Vitalograph Model 6600 CompactVitalograph (Ireland), Ltd.20150—
+3K142812Vitalograph Model 6800 PneumotracVitalograph (Ireland), Ltd.20151—
+4K212938Vitalograph Model 6000 AlphaVitalograph Ireland, Ltd.20221—
+5K251777MESI mTABLET SPIROMesi D.O.O.20260—