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FDA 510(k)

HALOGEN HEADLIGHT SYSTEM

K-Number: K810117 · 1981-02-10

ApplicantColmed, Ltd.
Decision Date1981-02-10
Product CodeEBA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HALOGEN HEADLIGHT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Colmed, Ltd.. It received FDA 510(k) clearance on 1981-02-10 under 510(k) number K810117. The device is classified under product code EBA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HALOGEN HEADLIGHT SYSTEM?

HALOGEN HEADLIGHT SYSTEM is a medical device that received FDA 510(k) clearance on 1981-02-10. The listed applicant is Colmed, Ltd.. The 510(k) number is K810117.

When did HALOGEN HEADLIGHT SYSTEM receive FDA 510(k) clearance?

HALOGEN HEADLIGHT SYSTEM received FDA 510(k) clearance on 1981-02-10, under 510(k) number K810117.

Who is the listed applicant for HALOGEN HEADLIGHT SYSTEM?

The FDA 510(k) record lists Colmed, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HALOGEN HEADLIGHT SYSTEM?

The FDA product code for HALOGEN HEADLIGHT SYSTEM is EBA.

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Other records listing Colmed, Ltd. 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.

K811209JACOB WIRZ TRANSFIXATION PINK810636VARIODRAINK801208HOLLOW BASKET TITANIUM DENTAL IMPLANTK801006CHARNLEY DESIGN HIP PROSTHESISK800762PS3 TITANIUM SCREW DENTAL IMPLANTK792241PELIMIT

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Related Devices (Code: EBA)

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.

K070287PS SERIES WITH FIBER LIGHT GUIDE AND HEADLIGHT, MODELS PS200, PS250, PS500Photonic Optische Gerate GmbH & CokgK923949SYLVAN DENTAL HEADLIGHT SYSTEMSylvan Medical FiberopticsK893458FIBEROPTIC HEADLIGHT SYSTEMCuda Products Co.K854646VEGA DENTAL OPERATING LIGHTAlpine Dental Equipment Co.K842515SURGICAL HEADLIGHTGood-Lite Co.K842358ISOLIGHTPlanmeca USA, Inc.

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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