510(k) Report

Devices descending from K081029

4 later devices reach Sleepstyle 200 Auto Series HC254 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110316Infosend GSMFisher & Paykel Healthcare, Ltd.20111—
+1K094040F&P Icon Series CpapFisher & Paykel Healthcare, Ltd.201011
+2K173193F&P SleepStyleFisher & Paykel Healthcare, Ltd.20180—
+2K161686F&P InfoSmartFisher & Paykel Healthcare, Ltd.20170—