510(k) Report

Devices descending from K090034

5 later devices reach Easy on-PC Spirometer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123896CCS-200 SpirometerBenson Medical Instruments Co.20134—
+2K130322SPM-300Bionet Co., Ltd.20133—
+3K220535Cardio10Bionet Co., Ltd.20222—
+4K231160Cardio Q50, Cardio Q70Bionet Co., Ltd.20230—
+4K231150Cardio P1Bionet Co., Ltd.20230—