510(k) Report

Devices descending from K002001

5 later devices reach Breeze Sleepgear with Dreamseal through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090804Nasal Aire II Pediatric, Model 5 Sizes, Model TBDInnomed Technologies, Inc./Respcare, Inc.20090—
+1K013738Weinmann SomnomaskGottlieb Weinmann Geraete Fuer Medizin Und Arbeits20023—
+2K061653Soyala Full Face MaskWeinmann Gerate Fur Medizin GmbH + Co. KG20062—
+3K073673Soyala Full Face Mask Gel VentedWeinmann Gerate Fur Medizin GmbH + Co. KG20081—
+4K112167Soyala Silkgel Full Face MaskWeinmann Gerate Fur Medizin GmbH + Co. KG20110—