510(k) Report

Devices descending from K110648

16 later devices reach Nova Stat Profile Phox Ultra Analyzer System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221900Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation20230—
+1K200349Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation20200—
+1K191626Stat Profile Prime ES Comp Plus Analyzer SystemNova Biomedical Corporation20190—
+1K191365Stat Profile Prime ES Comp Plus Analyzer SystemNova Biomedical Corporation20190—
+1K180340Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation20181—
+1K180186Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation20181—
+1K180428Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation20182—
+1K173797Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation20181—
+1K131703Nova Stat Profile Prime CCS Analyzer SystemNova Biomedical Corporation201431
+2K200403Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation202012
+2K200204Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation20200—
+2K193246Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation20200—
+2K141907Stat Profile Prime CCS Analyzer System, Stat Profile Prime Auto QC Cartridge CCS, Stat…Nova Biomedical Corporation201501
+2K142220Stat Profile Prime ABG Analyzer System (incl. Controls, Calibrators)Nova Biomedical Corporation201411
+3K252475ABL90 FLEX PLUS SystemRadiometer Medicals Aps20260—
+3K151982Stat Profile Prime ABG Analyzer SystemNova Biomedical Corporation201501