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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 the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Draeger Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2026-04-24 under 510(k) 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. The listed applicant is Shanghai Draeger Medical Instrument Co., Ltd.. The 510(k) number is K250349.

When did Vista CMS receive FDA 510(k) clearance?

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

Who is the listed applicant for Vista CMS?

The FDA 510(k) record lists Shanghai Draeger Medical Instrument Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vista CMS?

The FDA product code for Vista CMS is MHX.

Other records listing Shanghai Draeger Medical Instrument Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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)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

Related Devices (Code: MHX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc.K253277Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.K254209Radius VSM and AccessoriesMasimo CorporationK252840M12 Telemetry SystemGlobal Instrumentation, LLCK260098ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C /ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.K253170uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient MonitorsShenzhen Mindray Bio-Medical Electronics Co., Ltd.

Official Source

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

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