510(k) Report

Devices descending from K100011

3 later devices reach Fisher & Paykel Healthcare Bubble Cpap System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221436F&P 950 Accessory Breathing Circuit KitsFisher & Paykel Healthcare, Ltd.20230—
+1K143700CPAP CannulaideSalter Labs20150—
+1K131502Seattle - PapSeattle Childrens Hospital20130Class I