510(k) Report

Devices descending from K190512

1 later device reach SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212860SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack (SB-EMR-P…STERIS Corporation20210—