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FDA 510(k)

THE KEYMED HI-LIGHT 250 LIGHT SOURCE

K-Number: K864801 · 1986-12-24

ApplicantKeymed, Inc.
Decision Date1986-12-24
Product CodeGCT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

THE KEYMED HI-LIGHT 250 LIGHT SOURCE is the device name listed in this FDA 510(k) record. The listed applicant is Keymed, Inc.. It received FDA 510(k) clearance on 1986-12-24 under 510(k) number K864801. The device is classified under product code GCT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE KEYMED HI-LIGHT 250 LIGHT SOURCE?

THE KEYMED HI-LIGHT 250 LIGHT SOURCE is a medical device that received FDA 510(k) clearance on 1986-12-24. The listed applicant is Keymed, Inc.. The 510(k) number is K864801.

When did THE KEYMED HI-LIGHT 250 LIGHT SOURCE receive FDA 510(k) clearance?

THE KEYMED HI-LIGHT 250 LIGHT SOURCE received FDA 510(k) clearance on 1986-12-24, under 510(k) number K864801.

Who is the listed applicant for THE KEYMED HI-LIGHT 250 LIGHT SOURCE?

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

What is the FDA product code for THE KEYMED HI-LIGHT 250 LIGHT SOURCE?

The FDA product code for THE KEYMED HI-LIGHT 250 LIGHT SOURCE is GCT.

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Other records listing Keymed, Inc. as applicant

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Related Devices (Code: GCT)

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K093125ALPHAXENON LIGHT 180 W AND 300 WGimmi GmbHK082925XENON-100 SCB LIGHT SOURCE, MODEL 20132620KARL STORZ Endoscopy-America, Inc.K070376CONMED LINVATEC 300W XENON LIGHT SOURCEConmed LinvatecK040949VIADUCT MINISCOPE AND ACCESSORIESAcueity, Inc.K022490KSEA MEDI PACKKARL STORZ Endoscopy-America, Inc.K031994LINVATEC 300W XENON LIGHT SOURCELinvatec 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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