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FDA 510(k)

ALM PRISMALIX (PRX) SURGICAL LIGHT

K-Number: K982063 · 1998-09-22

ApplicantAlm Surgical Equipment, Inc.
Decision Date1998-09-22
Product CodeFSY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ALM PRISMALIX (PRX) SURGICAL LIGHT is the device name listed in this FDA 510(k) record. The listed applicant is Alm Surgical Equipment, Inc.. It received FDA 510(k) clearance on 1998-09-22 under 510(k) number K982063. 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 ALM PRISMALIX (PRX) SURGICAL LIGHT?

ALM PRISMALIX (PRX) SURGICAL LIGHT is a medical device that received FDA 510(k) clearance on 1998-09-22. The listed applicant is Alm Surgical Equipment, Inc.. The 510(k) number is K982063.

When did ALM PRISMALIX (PRX) SURGICAL LIGHT receive FDA 510(k) clearance?

ALM PRISMALIX (PRX) SURGICAL LIGHT received FDA 510(k) clearance on 1998-09-22, under 510(k) number K982063.

Who is the listed applicant for ALM PRISMALIX (PRX) SURGICAL LIGHT?

The FDA 510(k) record lists Alm Surgical Equipment, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALM PRISMALIX (PRX) SURGICAL LIGHT?

The FDA product code for ALM PRISMALIX (PRX) SURGICAL LIGHT is FSY.

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Other records listing Alm Surgical Equipment, Inc. 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.

K961886DRAGER GEMINA WALL-MOUNTED WORKPLACEK961742DRAGER DVE 8080/81/82 WITH DVE 4002 OR DVE 4001 SERIES SYSTEMK945102MTA:ANGENIEUX STARPOINT XE XENON LIGHT SOURCEK942043DRAGER DVE 8000/1/2 SERIES SYST W/DVE 4002 AND 8032EK922409ALM ILLUMINATOR SERIES LIGHT SYSTEMK921297DRAGER DVE 4000 SERIES SYSTEM

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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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