510(k) Report

Devices descending from K082766

5 later devices reach Modification to Minispir, Spirolab Iii through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122384MinispirMir Medical Intl. Research Srl20124—
+2K133051Pulmone Minibox PFT TMPulmone Advanced Medical Devices, Ltd.20143—
+3K141793Pulmone Miniboxpft 2.0Pulmone Advanced Medical Devices, Ltd.20152—
+4K161295MiniBox +Pulmone Advanced Medical Devices, Ltd.20161—
+5K240293STSTechbopulm, Ltd.20240—