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FDA 510(k)

XENON LIGHT SOURCE FOR ENDOSCOPIC PROCEDURES

K-Number: K863986 · 1986-10-31

ApplicantAmerican Edwards Laboratories
Decision Date1986-10-31
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

XENON LIGHT SOURCE FOR ENDOSCOPIC PROCEDURES is the device name listed in this FDA 510(k) record. The listed applicant is American Edwards Laboratories. It received FDA 510(k) clearance on 1986-10-31 under 510(k) number K863986. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XENON LIGHT SOURCE FOR ENDOSCOPIC PROCEDURES?

XENON LIGHT SOURCE FOR ENDOSCOPIC PROCEDURES is a medical device that received FDA 510(k) clearance on 1986-10-31. The listed applicant is American Edwards Laboratories. The 510(k) number is K863986.

When did XENON LIGHT SOURCE FOR ENDOSCOPIC PROCEDURES receive FDA 510(k) clearance?

XENON LIGHT SOURCE FOR ENDOSCOPIC PROCEDURES received FDA 510(k) clearance on 1986-10-31, under 510(k) number K863986.

Who is the listed applicant for XENON LIGHT SOURCE FOR ENDOSCOPIC PROCEDURES?

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

What is the FDA product code for XENON LIGHT SOURCE FOR ENDOSCOPIC PROCEDURES?

The FDA product code for XENON LIGHT SOURCE FOR ENDOSCOPIC PROCEDURES is HRX.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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