FDA 510(k)

PHORESOR II, MODEL PM900

K-Number: K974855 · 1998-03-27

Decision Date1998-03-27

Product CodeKTB

Advisory CommitteePM

DecisionSubstantially Equivalent for Some Indications

Device Summary

PHORESOR II, MODEL PM900 is the device name listed in this FDA 510(k) record. The listed applicant is Iomed, Inc.. It received FDA 510(k) clearance on 1998-03-27 under 510(k) number K974855. The device is classified under product code KTB. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the PHORESOR II, MODEL PM900?

PHORESOR II, MODEL PM900 is a medical device that received FDA 510(k) clearance on 1998-03-27. The listed applicant is Iomed, Inc.. The 510(k) number is K974855.

When did PHORESOR II, MODEL PM900 receive FDA 510(k) clearance?

PHORESOR II, MODEL PM900 received FDA 510(k) clearance on 1998-03-27, under 510(k) number K974855.

Who is the listed applicant for PHORESOR II, MODEL PM900?

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, MODEL PM900?

The FDA product code for PHORESOR II, MODEL PM900 is KTB.

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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: KTB)

K180627Macroduct Advanced Model 3710Elitechgroup, Inc.K033192RH-950Iomed, Inc.K031551NORTHSTAR LIDOCAINE IONTOPHORETIC CONTROLLER (NORTHSTAR CONTROLLER-D)Vyteris, Inc.K031115RH-900Iomed, Inc.K010031NANODUCT NEONATAL SWEAT ANALYSIS SYSTEMWescor, Inc.K001522TRANSQ3Iomed, Inc.

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.