510(k) Report

Devices descending from K082539

9 later devices reach Masterscope, Masterscope Ecg, Masterscope CT through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202754MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSUEresearchtechnology GmbH20211—
+1K150810Vyntus / SentrySuite Product LineCarefusion Germany 234 GmbH20155Class I
+1K091505COR12+Viasys Healthcare GmbH20096—
+2K223629SpiroSphere, SpiroSphereECG, CardioSphereEresearchtechnology GmbH20240—
+2K183567Vyntus/SentrySuite Product LineVyaire Medical20190—
+2K183369COR12 EcgCorscience GmbH & Co.20180—
+2K181524Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART…Vyaire Medical, Inc.20181—
+2K153654Sentry WEB SmartInterpCarefusion Germany 234 GmbH20160—
+3K190853Vyntus BODYVyaire Medical, Inc.20190—