FDA 510(k)

FREMS SSC DISPOSABLE FOAM ELECTRODES, MODEL 800-000-057; FREMS SSC DISPOSABLE NON-WOVEN ELECTRODES, MODEL 800-000-058

K-Number: K080902 · 2008-06-13

Decision Date2008-06-13

Product CodeGXY

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

FREMS SSC DISPOSABLE FOAM ELECTRODES, MODEL 800-000-057; FREMS SSC DISPOSABLE NON-WOVEN ELECTRODES, MODEL 800-000-058 is the device name listed in this FDA 510(k) record. The listed applicant is Lorenz Biotech S.P.A.. It received FDA 510(k) clearance on 2008-06-13 under 510(k) number K080902. 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 FREMS SSC DISPOSABLE FOAM ELECTRODES, MODEL 800-000-057; FREMS SSC DISPOSABLE NON-WOVEN ELECTRODES, MODEL 800-000-058?

FREMS SSC DISPOSABLE FOAM ELECTRODES, MODEL 800-000-057; FREMS SSC DISPOSABLE NON-WOVEN ELECTRODES, MODEL 800-000-058 is a medical device that received FDA 510(k) clearance on 2008-06-13. The listed applicant is Lorenz Biotech S.P.A.. The 510(k) number is K080902.

When did FREMS SSC DISPOSABLE FOAM ELECTRODES, MODEL 800-000-057; FREMS SSC DISPOSABLE NON-WOVEN ELECTRODES, MODEL 800-000-058 receive FDA 510(k) clearance?

FREMS SSC DISPOSABLE FOAM ELECTRODES, MODEL 800-000-057; FREMS SSC DISPOSABLE NON-WOVEN ELECTRODES, MODEL 800-000-058 received FDA 510(k) clearance on 2008-06-13, under 510(k) number K080902.

Who is the listed applicant for FREMS SSC DISPOSABLE FOAM ELECTRODES, MODEL 800-000-057; FREMS SSC DISPOSABLE NON-WOVEN ELECTRODES, MODEL 800-000-058?

The FDA 510(k) record lists Lorenz Biotech S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FREMS SSC DISPOSABLE FOAM ELECTRODES, MODEL 800-000-057; FREMS SSC DISPOSABLE NON-WOVEN ELECTRODES, MODEL 800-000-058?

The FDA product code for FREMS SSC DISPOSABLE FOAM ELECTRODES, MODEL 800-000-057; FREMS SSC DISPOSABLE NON-WOVEN ELECTRODES, MODEL 800-000-058 is GXY.

Related Clinical Trials

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.

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Other records listing Lorenz Biotech S.P.A. as applicant

K061828LORENZ BIOTECH APTIVA, VERSION 2.13

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Official Source

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