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FDA 510(k)

TRANSDERM IONTO SYSTEM, MK 2

K-Number: K042590 · 2004-10-14

ApplicantMattioli Engineering Corp.
Decision Date2004-10-14
Product CodeEGJ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

TRANSDERM IONTO SYSTEM, MK 2 is the device name listed in this FDA 510(k) record. The listed applicant is Mattioli Engineering Corp.. It received FDA 510(k) clearance on 2004-10-14 under 510(k) number K042590. 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 TRANSDERM IONTO SYSTEM, MK 2?

TRANSDERM IONTO SYSTEM, MK 2 is a medical device that received FDA 510(k) clearance on 2004-10-14. The listed applicant is Mattioli Engineering Corp.. The 510(k) number is K042590.

When did TRANSDERM IONTO SYSTEM, MK 2 receive FDA 510(k) clearance?

TRANSDERM IONTO SYSTEM, MK 2 received FDA 510(k) clearance on 2004-10-14, under 510(k) number K042590.

Who is the listed applicant for TRANSDERM IONTO SYSTEM, MK 2?

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

What is the FDA product code for TRANSDERM IONTO SYSTEM, MK 2?

The FDA product code for TRANSDERM IONTO SYSTEM, MK 2 is EGJ.

Related Clinical Trials

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Other records listing Mattioli Engineering Corp. 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.

K100053MATTIOLI PULSE TWO/THREE PLUS FAMILYK032968TRSANSDERM IONTO SYSTEM

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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