510(k) Report

Devices descending from K161534

2 later devices reach EasyOne Pro Respiratory Analysis System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221030Model 9100 PFT/DICOVitalograph Ireland, Ltd.20221—
+2K223818Model 9160 VitaloQUBVitalograph Ireland, Ltd.20230—