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FDA 510(k)

AIM 200, MAJOR SURGICAL LIGHT

K-Number: K101537 · 2010-09-30

ApplicantBurton Medical Products Corp.
Decision Date2010-09-30
Product CodeFSY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AIM 200, MAJOR SURGICAL LIGHT 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 2010-09-30 under 510(k) number K101537. 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 AIM 200, MAJOR SURGICAL LIGHT?

AIM 200, MAJOR SURGICAL LIGHT is a medical device that received FDA 510(k) clearance on 2010-09-30. The listed applicant is Burton Medical Products Corp.. The 510(k) number is K101537.

When did AIM 200, MAJOR SURGICAL LIGHT receive FDA 510(k) clearance?

AIM 200, MAJOR SURGICAL LIGHT received FDA 510(k) clearance on 2010-09-30, under 510(k) number K101537.

Who is the listed applicant for AIM 200, MAJOR SURGICAL LIGHT?

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 AIM 200, MAJOR SURGICAL LIGHT?

The FDA product code for AIM 200, MAJOR SURGICAL LIGHT 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.

K042395OUTPATIENT III MINOR SURGERY LIGHTK000639VISIONARY 2000K963682GENIE' 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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