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FDA 510(k)

MD VISION SYSTEM

K-Number: K101474 · 2010-07-02

ApplicantPerkins Healthcare Technologies
Decision Date2010-07-02
Product CodeDXJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MD VISION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Perkins Healthcare Technologies. It received FDA 510(k) clearance on 2010-07-02 under 510(k) number K101474. The device is classified under product code DXJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MD VISION SYSTEM?

MD VISION SYSTEM is a medical device that received FDA 510(k) clearance on 2010-07-02. The listed applicant is Perkins Healthcare Technologies. The 510(k) number is K101474.

When did MD VISION SYSTEM receive FDA 510(k) clearance?

MD VISION SYSTEM received FDA 510(k) clearance on 2010-07-02, under 510(k) number K101474.

Who is the listed applicant for MD VISION SYSTEM?

The FDA 510(k) record lists Perkins Healthcare Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MD VISION SYSTEM?

The FDA product code for MD VISION SYSTEM is DXJ.

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Related Devices (Code: DXJ)

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.

K212003ESSENZ Patient MonitorLivanova Deutschland, GmbHK212208Philips IntelliVue GuardianSoftware (Rev. E.0X)Philips Medizin Systeme Boeblingen GmbHK201162Essence 55SP Large Monitor SystemShenyang Torch-Bigtide Digital Technology Co., Ltd.K173107Vios Central Station Monitor Software, Vios Central Server SoftwareVios Medical, Inc.K180534Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbHK173381Nexxis ORBarco N.V.

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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