Class Class II

Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software 2050 (K241728)

K241728 2025-01-23 Traditional
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Description

Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software 2050 by Murata Vios, Inc., an FDA 510(k) cleared cardiovascular device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK241728
Clearance Date2025-01-23
Clearance TypeTraditional
Product CodeDXN
Regulation Number870.1130

Categories

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Predicate lineage for K241728

A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software 2050 (K241728) cites 3 predicate devices and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K173107Vios Central Station Monitor Software, Vios Central Server ...Vios Medical, Inc.2018
K172586Vios Monitoring System™ Model 2050Vios Medical, Inc.2018
K130709VISI MOBILE MONITORING SYSTEMSotera Wireless, Inc.2013

Trace the full predicate network for K241728

A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.

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