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FDA 510(k)

CHAMPION IONTOPHORETIC DRUG DELIVERY DEVICE

K-Number: K063465 · 2007-02-28

ApplicantIomed, Inc.
Decision Date2007-02-28
Product CodeEGJ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

CHAMPION IONTOPHORETIC DRUG DELIVERY DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Iomed, Inc.. It received FDA 510(k) clearance on 2007-02-28 under 510(k) number K063465. 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 CHAMPION IONTOPHORETIC DRUG DELIVERY DEVICE?

CHAMPION IONTOPHORETIC DRUG DELIVERY DEVICE is a medical device that received FDA 510(k) clearance on 2007-02-28. The listed applicant is Iomed, Inc.. The 510(k) number is K063465.

When did CHAMPION IONTOPHORETIC DRUG DELIVERY DEVICE receive FDA 510(k) clearance?

CHAMPION IONTOPHORETIC DRUG DELIVERY DEVICE received FDA 510(k) clearance on 2007-02-28, under 510(k) number K063465.

Who is the listed applicant for CHAMPION IONTOPHORETIC DRUG DELIVERY DEVICE?

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

What is the FDA product code for CHAMPION IONTOPHORETIC DRUG DELIVERY DEVICE?

The FDA product code for CHAMPION IONTOPHORETIC DRUG DELIVERY DEVICE is EGJ.

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Other records listing Iomed, 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.

K060236MW-1000 IONTOPHORETIC DRUG DELIVERY ELECTRODEK033192RH-950K031115RH-900K001522TRANSQ3K001410PHORESOR MODEL PM2000K982668PHORESOR II,MODEL PM900

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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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