FDA 510(k)

RH-900

K-Number: K031115 · 2003-07-10

Decision Date2003-07-10

Product CodeKTB

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

RH-900 is the device name listed in this FDA 510(k) record. The listed applicant is Iomed, Inc.. It received FDA 510(k) clearance on 2003-07-10 under 510(k) number K031115. The device is classified under product code KTB. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RH-900?

RH-900 is a medical device that received FDA 510(k) clearance on 2003-07-10. The listed applicant is Iomed, Inc.. The 510(k) number is K031115.

When did RH-900 receive FDA 510(k) clearance?

RH-900 received FDA 510(k) clearance on 2003-07-10, under 510(k) number K031115.

Who is the listed applicant for RH-900?

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 RH-900?

The FDA product code for RH-900 is KTB.

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.

K063465CHAMPION IONTOPHORETIC DRUG DELIVERY DEVICE K060236MW-1000 IONTOPHORETIC DRUG DELIVERY ELECTRODE K033192RH-950 K001522TRANSQ3 K001410PHORESOR MODEL PM2000 K982668PHORESOR II,MODEL PM900

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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.K010031NANODUCT NEONATAL SWEAT ANALYSIS SYSTEMWescor, Inc.K001522TRANSQ3Iomed, Inc.K001410PHORESOR MODEL PM2000Iomed, 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.