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FDA 510(k)

FIBEROPTIC HEADLIGHT SYSTEM

K-Number: K893458 · 1989-06-22

ApplicantCuda Products Co.
Decision Date1989-06-22
Product CodeEBA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FIBEROPTIC HEADLIGHT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Cuda Products Co.. It received FDA 510(k) clearance on 1989-06-22 under 510(k) number K893458. 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 FIBEROPTIC HEADLIGHT SYSTEM?

FIBEROPTIC HEADLIGHT SYSTEM is a medical device that received FDA 510(k) clearance on 1989-06-22. The listed applicant is Cuda Products Co.. The 510(k) number is K893458.

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

FIBEROPTIC HEADLIGHT SYSTEM received FDA 510(k) clearance on 1989-06-22, under 510(k) number K893458.

Who is the listed applicant for FIBEROPTIC HEADLIGHT SYSTEM?

The FDA 510(k) record lists Cuda Products Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FIBEROPTIC HEADLIGHT SYSTEM?

The FDA product code for FIBEROPTIC HEADLIGHT SYSTEM is EBA.

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Other records listing Cuda Products Co. 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.

K983277LIGHTSOURCE OR ILLUMINATOR MODEL I-100K981962CUDA PRODUCTS CORP. MODEL M300 (M-300) LIGHTSOURCEK981469CERMAX300 LIGHTSOURCEK980350VIDEO CAMERA/LIGHTSOURCE COMBINATION UNIT MODEL VCL-150K980166LIGHTSOURCE OR ILLUMINATORK961074LIGHTSOURCE OR ILLUMINATOR

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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 FiberopticsK854646VEGA DENTAL OPERATING LIGHTAlpine Dental Equipment Co.K842515SURGICAL HEADLIGHTGood-Lite Co.K842358ISOLIGHTPlanmeca USA, Inc.K822265FIBEROPTIC LIGHT SOURCE W/RELATED ITEMSKelleher Corp.

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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