510(k) Report

Devices descending from K993641

3 later devices reach Metalyzer, Model 2; Metalyzer, Model 3 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090722Shape-HF Cardiopulmonary Exercise Testing SystemShape Medical Systems, Inc.200922
+2K150888Shape-HF Cardiopulmonary Testing SystemShape Medical Systems, Inc.20160—
+2K093080Metaphor Metabolic MonitorTreymed, Inc.20100—