510(k) Report

Devices descending from K000648

12 later devices reach Spiro Pro through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173937SpiroSphereEresearchtechnology GmbH20190—
+1K031515Spiropro SPO2Viasys Healthcare GmbH200310—
+2K092324SpiroproViasys Healthcare GmbH20099—
+3K142959Vyntus WalkCarefusion Germany 234 GmbH20150—
+3K141936Microblab, MicroloopCarefusion Germany 234 GmbH20140—
+3K100687Vitalograph Hand Held Spirometer, Model 2120Vitalograph (Ireland), Ltd.20106—
+4K200550Vitalograph Model 2120 In2itive eDiaryVitalograph Ireland, Ltd.20202—
+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—