510(k) Report

Devices descending from K910077

4 later devices reach Crit-Scan through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K091564NBM-200MP Pulse Oximetry DeviceOrsense, Ltd.20102—
+1K983551Crit-Scan II MonitorIn-Line Diagnostics Corp.19990—
+2K124041NBM-200MPOrsense, Ltd.20131—
+3K142209Pulse oximeter NBM-200Orsense, Ltd.20150—