Cleared Traditional

K033192 - RH-950
(FDA 510(k) Clearance)

K033192 · Iomed, Inc. · Physical Medicine
Dec 2003
Decision
81d
Days
Class 2
Risk

K033192 is an FDA 510(k) clearance for the RH-950, a Device, Iontophoresis, Specific Uses (Class II — Special Controls, product code KTB), submitted by Iomed, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on December 22, 2003, 81 days after receiving the submission on October 2, 2003. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5525.

Submission Details

510(k) Number K033192 FDA.gov
FDA Decision Cleared SESE
Date Received October 02, 2003
Decision Date December 22, 2003
Days to Decision 81 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF

Device Classification

Product Code KTB — Device, Iontophoresis, Specific Uses
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5525