FDA 510(k)

PHORESOR II AUTO, MODEL PM800 MODIFICATION

K-Number: K934335 · 1994-07-26

Decision Date1994-07-26

Product CodeEGJ

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

PHORESOR II AUTO, MODEL PM800 MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Iomed, Inc.. It received FDA 510(k) clearance on 1994-07-26 under 510(k) number K934335. 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 PHORESOR II AUTO, MODEL PM800 MODIFICATION?

PHORESOR II AUTO, MODEL PM800 MODIFICATION is a medical device that received FDA 510(k) clearance on 1994-07-26. The listed applicant is Iomed, Inc.. The 510(k) number is K934335.

When did PHORESOR II AUTO, MODEL PM800 MODIFICATION receive FDA 510(k) clearance?

PHORESOR II AUTO, MODEL PM800 MODIFICATION received FDA 510(k) clearance on 1994-07-26, under 510(k) number K934335.

Who is the listed applicant for PHORESOR II AUTO, MODEL PM800 MODIFICATION?

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 PHORESOR II AUTO, MODEL PM800 MODIFICATION?

The FDA product code for PHORESOR II AUTO, MODEL PM800 MODIFICATION is EGJ.

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Other records listing Iomed, Inc. as applicant

K063465CHAMPION IONTOPHORETIC DRUG DELIVERY DEVICE K060236MW-1000 IONTOPHORETIC DRUG DELIVERY ELECTRODE K033192RH-950 K031115RH-900 K001522TRANSQ3 K001410PHORESOR MODEL PM2000

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Related Devices (Code: EGJ)

K242041STOPWET iontophoresis apparatus (SW01)Taiwan Medical Electronics Co., Ltd.K241267Hidroxa SE30Hidroxa Medical AB K232020Iontophoresis ElectrodesTop-Rank Health Care Co., Ltd.K192749DermadryDermadry Laboratories, Inc.K191436SaalioSaalmann Medical GmbH & Co. KG K170835Electro 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.