510(k) Report

Devices descending from K150810

5 later devices reach Vyntus / SentrySuite Product Line through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183567Vyntus/SentrySuite Product LineVyaire Medical20190—
+1K183369COR12 EcgCorscience GmbH & Co.20180—
+1K181524Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART…Vyaire Medical, Inc.20181—
+1K153654Sentry WEB SmartInterpCarefusion Germany 234 GmbH20160—
+2K190853Vyntus BODYVyaire Medical, Inc.20190—