510(k) Report

Devices descending from K052140

7 later devices reach Spirolab, Spirolab II through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082766Modification to Minispir, Spirolab IiiMir Medical Intl. Research Srl20085—
+1K061875Minispir; Spirolab IiiMir Medical Intl. Research Srl20060—
+2K122384MinispirMir Medical Intl. Research Srl20124—
+3K133051Pulmone Minibox PFT TMPulmone Advanced Medical Devices, Ltd.20143—
+4K141793Pulmone Miniboxpft 2.0Pulmone Advanced Medical Devices, Ltd.20152—
+5K161295MiniBox +Pulmone Advanced Medical Devices, Ltd.20161—
+6K240293STSTechbopulm, Ltd.20240—