FDA 510(k)

EVERLAST NEUROSTIMULATION ELECTRODES 2X 2,MODEL # EL2020

K-Number: K983741 · 1998-12-18

Decision Date1998-12-18

Product CodeGXY

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

EVERLAST NEUROSTIMULATION ELECTRODES 2X 2,MODEL # EL2020 is the device name listed in this FDA 510(k) record. The listed applicant is Axelgaard Mfg. Co., Ltd.. It received FDA 510(k) clearance on 1998-12-18 under 510(k) number K983741. 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 EVERLAST NEUROSTIMULATION ELECTRODES 2X 2,MODEL # EL2020?

EVERLAST NEUROSTIMULATION ELECTRODES 2X 2,MODEL # EL2020 is a medical device that received FDA 510(k) clearance on 1998-12-18. The listed applicant is Axelgaard Mfg. Co., Ltd.. The 510(k) number is K983741.

When did EVERLAST NEUROSTIMULATION ELECTRODES 2X 2,MODEL # EL2020 receive FDA 510(k) clearance?

EVERLAST NEUROSTIMULATION ELECTRODES 2X 2,MODEL # EL2020 received FDA 510(k) clearance on 1998-12-18, under 510(k) number K983741.

Who is the listed applicant for EVERLAST NEUROSTIMULATION ELECTRODES 2X 2,MODEL # EL2020?

The FDA 510(k) record lists Axelgaard Mfg. Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EVERLAST NEUROSTIMULATION ELECTRODES 2X 2,MODEL # EL2020?

The FDA product code for EVERLAST NEUROSTIMULATION ELECTRODES 2X 2,MODEL # EL2020 is GXY.

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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.