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FDA 510(k)

MACROLYTE DISPERSIVE ELECTRODE

K-Number: K120476 · 2012-06-12

ApplicantConmed Corporation
Decision Date2012-06-12
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MACROLYTE DISPERSIVE ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Conmed Corporation. It received FDA 510(k) clearance on 2012-06-12 under 510(k) number K120476. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MACROLYTE DISPERSIVE ELECTRODE?

MACROLYTE DISPERSIVE ELECTRODE is a medical device that received FDA 510(k) clearance on 2012-06-12. The listed applicant is Conmed Corporation. The 510(k) number is K120476.

When did MACROLYTE DISPERSIVE ELECTRODE receive FDA 510(k) clearance?

MACROLYTE DISPERSIVE ELECTRODE received FDA 510(k) clearance on 2012-06-12, under 510(k) number K120476.

Who is the listed applicant for MACROLYTE DISPERSIVE ELECTRODE?

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

What is the FDA product code for MACROLYTE DISPERSIVE ELECTRODE?

The FDA product code for MACROLYTE DISPERSIVE ELECTRODE is GEI.

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Related Devices (Code: GEI)

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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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