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FDA 510(k)

POWERLED SURGICAL LIGHT SYSTEM

K-Number: K070442 · 2007-03-16

ApplicantMaquet S.A.
Decision Date2007-03-16
Product CodeFSY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

POWERLED SURGICAL LIGHT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Maquet S.A.. It received FDA 510(k) clearance on 2007-03-16 under 510(k) number K070442. 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 POWERLED SURGICAL LIGHT SYSTEM?

POWERLED SURGICAL LIGHT SYSTEM is a medical device that received FDA 510(k) clearance on 2007-03-16. The listed applicant is Maquet S.A.. The 510(k) number is K070442.

When did POWERLED SURGICAL LIGHT SYSTEM receive FDA 510(k) clearance?

POWERLED SURGICAL LIGHT SYSTEM received FDA 510(k) clearance on 2007-03-16, under 510(k) number K070442.

Who is the listed applicant for POWERLED SURGICAL LIGHT SYSTEM?

The FDA 510(k) record lists Maquet S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POWERLED SURGICAL LIGHT SYSTEM?

The FDA product code for POWERLED SURGICAL LIGHT SYSTEM is FSY.

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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

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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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