510(k) Report

Devices descending from K013812

9 later devices reach Spirolab II, Model 29 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061571ASTRA 300Sdi Diagnostics, Inc.20070—
+1K052140Spirolab, Spirolab IIMir Medical Intl. Research Srl20067—
+2K082766Modification to Minispir, Spirolab IiiMir Medical Intl. Research Srl20085—
+2K061875Minispir; Spirolab IiiMir Medical Intl. Research Srl20060—
+3K122384MinispirMir Medical Intl. Research Srl20124—
+4K133051Pulmone Minibox PFT TMPulmone Advanced Medical Devices, Ltd.20143—
+5K141793Pulmone Miniboxpft 2.0Pulmone Advanced Medical Devices, Ltd.20152—
+6K161295MiniBox +Pulmone Advanced Medical Devices, Ltd.20161—
+7K240293STSTechbopulm, Ltd.20240—