510(k) Report

Devices descending from K120635

3 later devices reach Easyone Pro Respiratory Testing Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161534EasyOne Pro Respiratory Analysis SystemNdd Medizintechnik AG201722
+2K221030Model 9100 PFT/DICOVitalograph Ireland, Ltd.20221—
+3K223818Model 9160 VitaloQUBVitalograph Ireland, Ltd.20230—