510(k) Report

Devices descending from K063096

5 later devices reach Precision Oxygen Monitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153659MaxO2MEMaxtec, LLC20164—
+2K221734Maxtec MaxO2 ME+pMaxtec, LLC20232—
+2K213948OxyMinderBio-Med Devices, Inc.20220—
+3K251245OxyMinder Pro (10310)Bio-Med Device, Inc.20250—
+3K231895Maxtec MaxBlend2+pMaxtec, LLC20230—