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FDA 510(k)

HANAULUX BLUE 80 HOSPITAL

K-Number: K970886 · 1997-04-16

ApplicantHeraeus Med GmbH
Decision Date1997-04-16
Product CodeFSS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HANAULUX BLUE 80 HOSPITAL 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 1997-04-16 under 510(k) number K970886. The device is classified under product code FSS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HANAULUX BLUE 80 HOSPITAL?

HANAULUX BLUE 80 HOSPITAL is a medical device that received FDA 510(k) clearance on 1997-04-16. The listed applicant is Heraeus Med GmbH. The 510(k) number is K970886.

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

HANAULUX BLUE 80 HOSPITAL received FDA 510(k) clearance on 1997-04-16, under 510(k) number K970886.

Who is the listed applicant for HANAULUX BLUE 80 HOSPITAL?

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 80 HOSPITAL?

The FDA product code for HANAULUX BLUE 80 HOSPITAL is FSS.

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 120K954169HANAULUX BLUE 30 & 80

Related Devices (Code: FSS)

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.

K091246ILED 3 MOBILE (I300M), TRULIGHT 5500 MOBILE (T500M), TRULIGHT 5300 MOBILE (T300M)Trumpf Medizin Systeme GmbH + Co. KGK003489NEXT GENERAL M20 SURGICAL LIGHT; NEXT GENERATION M16 MINOR SURGERY LIGHT; NEXT GENERATION SPOTLIGHT; NEXT GENERATION M8Medical Illumination International, Inc.K984124AESCULAP XENON LIGHT SOURCEAesculap, Inc.K981962CUDA PRODUCTS CORP. MODEL M300 (M-300) LIGHTSOURCECuda Products Co.K981821VES 3001/2 DUAL OUTPUT VIDEO ILLUMINATORAngiolaz, Inc.K981469CERMAX300 LIGHTSOURCECuda Products Co.

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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