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FDA 510(k)

HANAULUX BLUE 30 & 80

K-Number: K954169 · 1996-02-01

ApplicantHeraeus Med GmbH
Decision Date1996-02-01
Product CodeFSY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HANAULUX BLUE 30 & 80 is the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Med GmbH. It received FDA 510(k) clearance on 1996-02-01 under 510(k) number K954169. 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 HANAULUX BLUE 30 & 80?

HANAULUX BLUE 30 & 80 is a medical device that received FDA 510(k) clearance on 1996-02-01. The listed applicant is Heraeus Med GmbH. The 510(k) number is K954169.

When did HANAULUX BLUE 30 & 80 receive FDA 510(k) clearance?

HANAULUX BLUE 30 & 80 received FDA 510(k) clearance on 1996-02-01, under 510(k) number K954169.

Who is the listed applicant for HANAULUX BLUE 30 & 80?

The FDA 510(k) record lists Heraeus Med GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HANAULUX BLUE 30 & 80?

The FDA product code for HANAULUX BLUE 30 & 80 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 Heraeus Med GmbH 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.

K973466HANAULUX BLUE 75 AND HANAULUX BLUE 120K970886HANAULUX BLUE 80 HOSPITAL

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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