510(k) Report

Devices descending from K080212

5 later devices reach Medela Thopaz, Model 200 0288 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130210Medela ThopazMedela AG20132—
+1K103042Atmos E 201 Thorax and Atmos S 201 ThoraxAtmos, Inc.20111—
+2K241799ATMOS C 051 Thorax (317.0200.0); Secretion canister 800ml (317.1300.0); Hose system…Atmos Medizintechnik GmbH & Co. KG20250—
+2K141553Medela Thopaz+Medela AG20141—
+3K181667Thoraguard SystemCentese, Inc.20180—