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FDA 510(k)

DERMASENSE PLUS DISPERSIVE ELECTRODE

K-Number: K980171 · 1998-02-27

ApplicantHorizon Medical, Inc.
Decision Date1998-02-27
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DERMASENSE PLUS DISPERSIVE ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Horizon Medical, Inc.. It received FDA 510(k) clearance on 1998-02-27 under 510(k) number K980171. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DERMASENSE PLUS DISPERSIVE ELECTRODE?

DERMASENSE PLUS DISPERSIVE ELECTRODE is a medical device that received FDA 510(k) clearance on 1998-02-27. The listed applicant is Horizon Medical, Inc.. The 510(k) number is K980171.

When did DERMASENSE PLUS DISPERSIVE ELECTRODE receive FDA 510(k) clearance?

DERMASENSE PLUS DISPERSIVE ELECTRODE received FDA 510(k) clearance on 1998-02-27, under 510(k) number K980171.

Who is the listed applicant for DERMASENSE PLUS DISPERSIVE ELECTRODE?

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

What is the FDA product code for DERMASENSE PLUS DISPERSIVE ELECTRODE?

The FDA product code for DERMASENSE PLUS DISPERSIVE ELECTRODE is GEI.

Related Clinical Trials

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Other records listing Horizon Medical, Inc. as applicant

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.

K944969STERI-LUB LUBRICATION GELK883576HORIZON ORTHOPEDIC PIN PROTECTOR

Related Devices (Code: GEI)

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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Official Source

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