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FDA 510(k)

XENON FIBEROPTIC LIGHT SOURCE, MODEL 1300 XSBP

K-Number: K022384 · 2002-10-18

ApplicantIsolux America
Decision Date2002-10-18
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

XENON FIBEROPTIC LIGHT SOURCE, MODEL 1300 XSBP is the device name listed in this FDA 510(k) record. The listed applicant is Isolux America. It received FDA 510(k) clearance on 2002-10-18 under 510(k) number K022384. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XENON FIBEROPTIC LIGHT SOURCE, MODEL 1300 XSBP?

XENON FIBEROPTIC LIGHT SOURCE, MODEL 1300 XSBP is a medical device that received FDA 510(k) clearance on 2002-10-18. The listed applicant is Isolux America. The 510(k) number is K022384.

When did XENON FIBEROPTIC LIGHT SOURCE, MODEL 1300 XSBP receive FDA 510(k) clearance?

XENON FIBEROPTIC LIGHT SOURCE, MODEL 1300 XSBP received FDA 510(k) clearance on 2002-10-18, under 510(k) number K022384.

Who is the listed applicant for XENON FIBEROPTIC LIGHT SOURCE, MODEL 1300 XSBP?

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

What is the FDA product code for XENON FIBEROPTIC LIGHT SOURCE, MODEL 1300 XSBP?

The FDA product code for XENON FIBEROPTIC LIGHT SOURCE, MODEL 1300 XSBP is HET.

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Other records listing Isolux America 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.

K991572ISOLUX SURGICAL HEADLIGHTK991208ENDOSCOPIC FIBEROPTIC CABLE

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Official Source

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