510(k) Report

Devices descending from K032056

4 later devices reach Bilevel Cpap, Model 9055 Series through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093070Devilbiss Intellipap/ Sleepcube Bilevel ST, DV56 ST SeriesSunrise Medical20100—
+1K091919Devilbiss Intellipap/Sleepcube Bilevel S/STSunrise Medical200911
+1K043282Devilbiss Autoadjust, Model 9054 SeriesSunrise Medical20050—
+2K112220Devilbiss Intellipap / Sleepcube Auto BilevelDevilbiss Healthcare, LLC201101