510(k) Report

Devices descending from K942211

14 later devices reach VMAX229 Series Pulmonary/Metabolic Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120635Easyone Pro Respiratory Testing DeviceNdd Medizitechnik AG20123—
+1K102047Lci Option for InnocorInnovision A/S201101
+1K091428Easyone Pro Respiratory Analysis SystemNdd Medizitechnik AG20103—
+1K052328Zan Lung-Function LabZan Messgerate GmbH20054—
+1K030464Gem, Model 004110Collins Medical, Inc.20031—
+1K974200Orca Cardiopulmonary Exercise Testing SystemOrca Diagnostics Corp.19980—
+2K161534EasyOne Pro Respiratory Analysis SystemNdd Medizintechnik AG201722
+2K161295MiniBox +Pulmone Advanced Medical Devices, Ltd.20161—
+2K133051Pulmone Minibox PFT TMPulmone Advanced Medical Devices, Ltd.20143—
+2K030917Gem; Hawk; Eagle; Models 004110, 0044120, 004130Collins Medical, Inc.20030—
+3K240293STSTechbopulm, Ltd.20240—
+3K221030Model 9100 PFT/DICOVitalograph Ireland, Ltd.20221—
+3K141793Pulmone Miniboxpft 2.0Pulmone Advanced Medical Devices, Ltd.20152—
+4K223818Model 9160 VitaloQUBVitalograph Ireland, Ltd.20230—