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FDA 510(k)

COLUMBIA 600 ELECTRODE, COLUMBIA 06 LEADWIRE

K-Number: K080386 · 2008-05-30

ApplicantColumbia Scientific Development, LLC
Decision Date2008-05-30
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

COLUMBIA 600 ELECTRODE, COLUMBIA 06 LEADWIRE is the device name listed in this FDA 510(k) record. The listed applicant is Columbia Scientific Development, LLC. It received FDA 510(k) clearance on 2008-05-30 under 510(k) number K080386. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLUMBIA 600 ELECTRODE, COLUMBIA 06 LEADWIRE?

COLUMBIA 600 ELECTRODE, COLUMBIA 06 LEADWIRE is a medical device that received FDA 510(k) clearance on 2008-05-30. The listed applicant is Columbia Scientific Development, LLC. The 510(k) number is K080386.

When did COLUMBIA 600 ELECTRODE, COLUMBIA 06 LEADWIRE receive FDA 510(k) clearance?

COLUMBIA 600 ELECTRODE, COLUMBIA 06 LEADWIRE received FDA 510(k) clearance on 2008-05-30, under 510(k) number K080386.

Who is the listed applicant for COLUMBIA 600 ELECTRODE, COLUMBIA 06 LEADWIRE?

The FDA 510(k) record lists Columbia Scientific Development, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COLUMBIA 600 ELECTRODE, COLUMBIA 06 LEADWIRE?

The FDA product code for COLUMBIA 600 ELECTRODE, COLUMBIA 06 LEADWIRE is GXY.

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Official Source

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