510(k) Report

Devices descending from K984031

10 later devices reach Spirovit, Model SP-250 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K992823Spirovit SP-2, Pneumocheck IISchiller AG20009—
+2K022276KokomateFerraris Respiratory, Inc.20028—
+3K051572Koko LegendPulmonary Data Services, Inc.20057—
+4K100687Vitalograph Hand Held Spirometer, Model 2120Vitalograph (Ireland), Ltd.20106—
+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—