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FDA 510(k)

VISIONARY 2000

K-Number: K000639 · 2000-05-25

ApplicantBurton Medical Products Corp.
Decision Date2000-05-25
Product CodeFSY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VISIONARY 2000 is the device name listed in this FDA 510(k) record. The listed applicant is Burton Medical Products Corp.. It received FDA 510(k) clearance on 2000-05-25 under 510(k) number K000639. The device is classified under product code FSY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VISIONARY 2000?

VISIONARY 2000 is a medical device that received FDA 510(k) clearance on 2000-05-25. The listed applicant is Burton Medical Products Corp.. The 510(k) number is K000639.

When did VISIONARY 2000 receive FDA 510(k) clearance?

VISIONARY 2000 received FDA 510(k) clearance on 2000-05-25, under 510(k) number K000639.

Who is the listed applicant for VISIONARY 2000?

The FDA 510(k) record lists Burton Medical Products Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VISIONARY 2000?

The FDA product code for VISIONARY 2000 is FSY.

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Other records listing Burton Medical Products Corp. 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.

K101537AIM 200, MAJOR SURGICAL LIGHTK042395OUTPATIENT III MINOR SURGERY LIGHTK963682GENIE' SINGLE CEILING AND DOUBLE CEILINGK961843GENIEK935102SATURN LIGHTK942553GENESIS

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Related Devices (Code: FSY)

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.

K132747VISUM BLADE LED SURGICAL LIGHTING SYSTEMStryker CommunicationsK132307VIDA LED SURGICAL LIGHTING SYSTEMConvida Healthcare & Systems CorporationK131893AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTSAjw Technology Consultants, Inc.K122875ORICARE L2700Oricare, Inc.K120392CHROMOPHARE F 628 AND F 528Berchtold GmbH & Co. KGK102758TRULIGHT 5520 AND TRULIGHT 5320Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg

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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