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FDA 510(k)

HANAULUX BLUE 75 AND HANAULUX BLUE 120

K-Number: K973466 · 1997-10-24

ApplicantHeraeus Med GmbH
Decision Date1997-10-24
Product CodeFSY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HANAULUX BLUE 75 AND HANAULUX BLUE 120 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 1997-10-24 under 510(k) number K973466. 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 75 AND HANAULUX BLUE 120?

HANAULUX BLUE 75 AND HANAULUX BLUE 120 is a medical device that received FDA 510(k) clearance on 1997-10-24. The listed applicant is Heraeus Med GmbH. The 510(k) number is K973466.

When did HANAULUX BLUE 75 AND HANAULUX BLUE 120 receive FDA 510(k) clearance?

HANAULUX BLUE 75 AND HANAULUX BLUE 120 received FDA 510(k) clearance on 1997-10-24, under 510(k) number K973466.

Who is the listed applicant for HANAULUX BLUE 75 AND HANAULUX BLUE 120?

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 75 AND HANAULUX BLUE 120?

The FDA product code for HANAULUX BLUE 75 AND HANAULUX BLUE 120 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.

K970886HANAULUX BLUE 80 HOSPITALK954169HANAULUX BLUE 30 & 80

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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