510(k) Report

Devices descending from K052119

6 later devices reach Teslaguard, Model Eft G04 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071802Tesla Guard, Model Eft G04Mammendorfer Institut Fur Physik Und Medizin GmbH20075—
+2K142032Mri Patient Monitoring System Tesla M3Mipm Mammendorfer Institut Fur Physik Und Medizin20154—
+3K1722003880 MRI Patient Monitoring SystemIradimed Corporation20172—
+3K153739MRI Patient Monitor TeslaDUOMipm Mammendorfer Institut Fur Physik Und Medizin20160—
+4K1809033880 MRI Patient Monitoring SystemIradimed Corporation20190—
+4K1829003880 MRI Patient Monitoring SystemIradimed Corporation20180—