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FDA 510(k)

DISPOSABLE ADHESIVE SURFACE ELECTRODE

K-Number: K120494 · 2012-06-11

ApplicantSpes Medica Srl
Decision Date2012-06-11
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE ADHESIVE SURFACE ELECTRODE 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 2012-06-11 under 510(k) number K120494. 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 DISPOSABLE ADHESIVE SURFACE ELECTRODE?

DISPOSABLE ADHESIVE SURFACE ELECTRODE is a medical device that received FDA 510(k) clearance on 2012-06-11. The listed applicant is Spes Medica Srl. The 510(k) number is K120494.

When did DISPOSABLE ADHESIVE SURFACE ELECTRODE receive FDA 510(k) clearance?

DISPOSABLE ADHESIVE SURFACE ELECTRODE received FDA 510(k) clearance on 2012-06-11, under 510(k) number K120494.

Who is the listed applicant for DISPOSABLE ADHESIVE SURFACE ELECTRODE?

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 DISPOSABLE ADHESIVE SURFACE ELECTRODE?

The FDA product code for DISPOSABLE ADHESIVE SURFACE ELECTRODE is GXY.

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Related Devices (Code: GXY)

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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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