510(k) Report

Devices descending from K970785

2 later devices reach Sims Hyperinflation Bag System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092687Venti.Plus Hyperinflation Bag System with Pressure ManometerA Plus Medical20091—
+2K102377Ventiplus Disposable Manometer 0-60 CM H2O; Ventiplus Disposable Manometer 0-20 CM H2O…A Plus Medical20100—