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FDA 510(k)

Vista CMS

K-Number: K250349 · 2026-04-24

ApplicantShanghai Draeger Medical Instrument Co., Ltd.
Decision Date2026-04-24
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Vista CMS is a medical device manufactured by Shanghai Draeger Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2026-04-24 under approval number K250349. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vista CMS?

Vista CMS is a medical device that received FDA 510(k) clearance on 2026-04-24. It is manufactured by Shanghai Draeger Medical Instrument Co., Ltd.. The 510(k) number is K250349.

When was Vista CMS approved by the FDA?

Vista CMS received FDA 510(k) clearance on 2026-04-24, under approval number K250349.

What company makes Vista CMS?

Vista CMS is manufactured by Shanghai Draeger Medical Instrument Co., Ltd..

What is the FDA product code for Vista CMS?

The FDA product code for Vista CMS is MHX.

Other Devices by Shanghai Draeger Medical Instrument Co., Ltd.

K251669IBP transducer adapter cable, Argon/BD/Ohmeda, 2m; IBP transducer adapter cable, Draeger 10-pin, 2m; IBP transducer adapter cable, Draeger 7-pin, 2m; IBP transd. adapter cbl, Abbott/Medex, Smiths/TranStar 2m; IBP transducer adapter cable, Baxter/Edwards, 0.3m; IBP transducer adapter cable, Baxter/Edwards, 2m; IBP transducer adapter cable, Argon/BD/Ohmeda, 0.3m; IBP transducer adapter cable, Draeger 10-pin, 0.3m; IBP transducer adapter cable, Draeger 7-pin, 0.3m; IBP transducer adapter K252250Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model C, US (2601065); Vista 300 S Non-Inv Model A, US (2602425); Vista 300 S Invasive Model B, US (2602426); Vista 300 S Invasive Model C, US (2602427)

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K160981Patient MonitorEdan Instruments, Inc. K153707Nihon Kohden Vital Sign TelemeterNihon Kohden Corporation K160685Surveyor S4 Mobile MonitorMortara Instrument, Inc. K161531IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2; IntelliVue Patient Monitors MP20, MP30, MP40, MP50, MP60; IntelliVue Patient Monitors MP70, MP80, MP90;IntelliVue Patient Monitors MX400, MX430, MX450, MX500, MX550, MX600;IntelliVue Patient Monitors MX700, MX800Philips Medizin Systeme Boeblingen GmbH K153702M3290B Philips IntelliVue Information Center iXPhilips Medical Systems K160951Philips Efficia CMS200 Central Monitoring SystemPhilips Medical Systems

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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