FDA 510(k)

SENSORY NERVE ELECTRODES-TWO FINGER RINGS, STIMULATOR PROBE ELECTRODES-FACIAL, MONO, BI- & TRIPOLAR NERVE STIMULATORS

K-Number: K083758 · 2009-08-14

Decision Date2009-08-14

Product CodeGXY

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

SENSORY NERVE ELECTRODES-TWO FINGER RINGS, STIMULATOR PROBE ELECTRODES-FACIAL, MONO, BI- & TRIPOLAR NERVE STIMULATORS is the device name listed in this FDA 510(k) record. The listed applicant is The Electrode Store, Inc.. It received FDA 510(k) clearance on 2009-08-14 under 510(k) number K083758. 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 SENSORY NERVE ELECTRODES-TWO FINGER RINGS, STIMULATOR PROBE ELECTRODES-FACIAL, MONO, BI- & TRIPOLAR NERVE STIMULATORS?

SENSORY NERVE ELECTRODES-TWO FINGER RINGS, STIMULATOR PROBE ELECTRODES-FACIAL, MONO, BI- & TRIPOLAR NERVE STIMULATORS is a medical device that received FDA 510(k) clearance on 2009-08-14. The listed applicant is The Electrode Store, Inc.. The 510(k) number is K083758.

When did SENSORY NERVE ELECTRODES-TWO FINGER RINGS, STIMULATOR PROBE ELECTRODES-FACIAL, MONO, BI- & TRIPOLAR NERVE STIMULATORS receive FDA 510(k) clearance?

SENSORY NERVE ELECTRODES-TWO FINGER RINGS, STIMULATOR PROBE ELECTRODES-FACIAL, MONO, BI- & TRIPOLAR NERVE STIMULATORS received FDA 510(k) clearance on 2009-08-14, under 510(k) number K083758.

Who is the listed applicant for SENSORY NERVE ELECTRODES-TWO FINGER RINGS, STIMULATOR PROBE ELECTRODES-FACIAL, MONO, BI- & TRIPOLAR NERVE STIMULATORS?

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

What is the FDA product code for SENSORY NERVE ELECTRODES-TWO FINGER RINGS, STIMULATOR PROBE ELECTRODES-FACIAL, MONO, BI- & TRIPOLAR NERVE STIMULATORS?

The FDA product code for SENSORY NERVE ELECTRODES-TWO FINGER RINGS, STIMULATOR PROBE ELECTRODES-FACIAL, MONO, BI- & TRIPOLAR NERVE STIMULATORS is GXY.

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Other records listing The Electrode Store, Inc. as applicant

K022197SURFACE ELECTRODE FOR ELECTROENCEPHALOGRAPHY K020910SUBDERMAL NEEDLE ELECTRODE FOR ELECTROENCEPHALOGRAPHY, MODELS PRO-E12SAF AND DEN-12SAF K020445THE ELECTRODE STORE SURFACE (CUTANEOUS) ELECTRODE FOR EMG K926094PROTECTRODE SYSTEM K932691PROTECTRODE SYSTEMS CONCENTRIC

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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.