510(k) Report

Devices descending from K961346

2 later devices reach PH Analysis Module through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K981733Digitrapper Delta, Model 9043G0201 and Polygram '98 PH Extension Model 9043S0111Medtronic Functional Diagnostics A/S199911
+2K011471Bilitec 2000, Polygram '98 PH Testing Application (Incl.Bile), Optical Fiber ProberMedtronic Functional Diagnostics A/S20020—