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FDA 510(k)

Spes Medica Subdermal Needle Electrodes

K-Number: K192603 · 2019-11-22

ApplicantSpes Medica Srl
Decision Date2019-11-22
Product CodeGXZ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Spes Medica Subdermal Needle Electrodes is the device name listed in this FDA 510(k) record. The listed applicant is Spes Medica Srl. It received FDA 510(k) clearance on 2019-11-22 under 510(k) number K192603. The device is classified under product code GXZ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Spes Medica Subdermal Needle Electrodes?

Spes Medica Subdermal Needle Electrodes is a medical device that received FDA 510(k) clearance on 2019-11-22. The listed applicant is Spes Medica Srl. The 510(k) number is K192603.

When did Spes Medica Subdermal Needle Electrodes receive FDA 510(k) clearance?

Spes Medica Subdermal Needle Electrodes received FDA 510(k) clearance on 2019-11-22, under 510(k) number K192603.

Who is the listed applicant for Spes Medica Subdermal Needle Electrodes?

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

What is the FDA product code for Spes Medica Subdermal Needle Electrodes?

The FDA product code for Spes Medica Subdermal Needle Electrodes is GXZ.

Other records listing Spes Medica Srl as applicant

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Related Devices (Code: GXZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241045Disposable Subdermal Needle Electrode, CorkscrewTechnomed EuropeK232581Medical Disposable Sterile Needle ElectrodeSuzhou Haishen Medical Device Associates Co., Ltd.K231691Phantom XL Insulated DilatorsTeDan Surgical Innovations, Inc.K200984Guardian Needle ElectrodeRhythmlink International, LLCK190801PressOn Electrode HeadsetRhythmlink International, LLCK161566DMS Disposable Subdermal Needle ElectrodesDaehan Medical Systems Co., Ltd.

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.

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