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FDA 510(k)

MODIFICATION TO PRISMALIX SURGICAL LIGHT

K-Number: K040015 · 2004-01-21

ApplicantAlm S.A.
Decision Date2004-01-21
Product CodeFSY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO PRISMALIX SURGICAL LIGHT is the device name listed in this FDA 510(k) record. The listed applicant is Alm S.A.. It received FDA 510(k) clearance on 2004-01-21 under 510(k) number K040015. 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 MODIFICATION TO PRISMALIX SURGICAL LIGHT?

MODIFICATION TO PRISMALIX SURGICAL LIGHT is a medical device that received FDA 510(k) clearance on 2004-01-21. The listed applicant is Alm S.A.. The 510(k) number is K040015.

When did MODIFICATION TO PRISMALIX SURGICAL LIGHT receive FDA 510(k) clearance?

MODIFICATION TO PRISMALIX SURGICAL LIGHT received FDA 510(k) clearance on 2004-01-21, under 510(k) number K040015.

Who is the listed applicant for MODIFICATION TO PRISMALIX SURGICAL LIGHT?

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

What is the FDA product code for MODIFICATION TO PRISMALIX SURGICAL LIGHT?

The FDA product code for MODIFICATION TO PRISMALIX SURGICAL LIGHT is FSY.

Related Clinical Trials

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.

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Other records listing Alm S.A. 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.

K040735ALM X'TEN (X10) SURGICAL LIGHT SYSTEM

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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