510(k) Report

Devices descending from K202943

5 later devices reach OptoMonitor 3 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213854SavvyWireOpsens, Inc.20224—
+2K252674Solo Pace Fusion System (SOLOFUSE1)Solo Pace, Inc.20260—
+2K241418OptoMonitor 3Opsens, Inc.20251—
+2K240864PacePro WireOpsens, Inc.20240—
+3K251367OptoMonitor 3Opsens, Inc.20260—