510(k) Report

Devices descending from K060405

5 later devices reach Soyala, Soyala Blue through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081014Soyala Gel VentedWeinmann Gerate Fur Medizin GmbH + Co. KG20081—
+1K061653Soyala Full Face MaskWeinmann Gerate Fur Medizin GmbH + Co. KG20062—
+2K110884Easyfit Silkgel Nasal MaskWeinmann Gerate Fur Medizin GmbH + Co. KG20110—
+2K073673Soyala Full Face Mask Gel VentedWeinmann Gerate Fur Medizin GmbH + Co. KG20081—
+3K112167Soyala Silkgel Full Face MaskWeinmann Gerate Fur Medizin GmbH + Co. KG20110—