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FDA 510(k)

DUPEL B.L.U.E. SMALL IONTOPHORESIS ELECTRODE

K-Number: K983484 · 1998-12-28

ApplicantEmpi
Decision Date1998-12-28
Product CodeEGJ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

DUPEL B.L.U.E. SMALL IONTOPHORESIS ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Empi. It received FDA 510(k) clearance on 1998-12-28 under 510(k) number K983484. The device is classified under product code EGJ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DUPEL B.L.U.E. SMALL IONTOPHORESIS ELECTRODE?

DUPEL B.L.U.E. SMALL IONTOPHORESIS ELECTRODE is a medical device that received FDA 510(k) clearance on 1998-12-28. The listed applicant is Empi. The 510(k) number is K983484.

When did DUPEL B.L.U.E. SMALL IONTOPHORESIS ELECTRODE receive FDA 510(k) clearance?

DUPEL B.L.U.E. SMALL IONTOPHORESIS ELECTRODE received FDA 510(k) clearance on 1998-12-28, under 510(k) number K983484.

Who is the listed applicant for DUPEL B.L.U.E. SMALL IONTOPHORESIS ELECTRODE?

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

What is the FDA product code for DUPEL B.L.U.E. SMALL IONTOPHORESIS ELECTRODE?

The FDA product code for DUPEL B.L.U.E. SMALL IONTOPHORESIS ELECTRODE is EGJ.

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Other records listing Empi 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.

K093324EMPI CONTINUUMK090922EMPI ACTIVE TRANSCUTANEOUS NERVE STIMULATORK072946HYBRESIS IONTOPHORESIS DRUG DELIVERY SYSTEMK070427DUPEL TRANSPORT IONTOPHORESIS SYSTEMK061650SELECT TENS, MODEL 4600SK041920INFINITY PLUS ELECTROTHERAPY SYSTEM

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Related Devices (Code: EGJ)

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.

K242041STOPWET iontophoresis apparatus (SW01)Taiwan Medical Electronics Co., Ltd.K241267Hidroxa SE30Hidroxa Medical ABK232020Iontophoresis ElectrodesTop-Rank Health Care Co., Ltd.K192749DermadryDermadry Laboratories, Inc.K191436SaalioSaalmann Medical GmbH & Co. KGK170835Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITEHightech Development

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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