510(k) Report

Devices descending from K970158

2 later devices reach Babypac through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K043495BabypacSmiths Medical International Ltd., Luton20051—
+2K121379Pneuton Mini Ventilator Pneuton Mini Non-Invasive Ventilation (Niv) Kit AccessoryAiron Corporation20120—