510(k) Report

Devices descending from K122539

4 later devices reach Measurement of PH in Pleural Fluid on Blood Gas System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192240RAPIDPoint 500e Blood Gas SystemSiemens Healthcare Diagnostics, Inc.202034
+2K230285i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.20230—
+2K223857i-STAT G3+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.202311
+3K244014i-STAT CG4+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.202501