Cleared Traditional

IMMERSION HYDROBATH

K082951 · Arjo Hospital Equipment AB · Physical Medicine
Apr 2009
Decision
187d
Days
Class 2
Risk

About This 510(k) Submission

K082951 is an FDA 510(k) clearance for the IMMERSION HYDROBATH, a Bath, Hydro-massage (Class II — Special Controls, product code ILJ), submitted by Arjo Hospital Equipment AB (Roselle, US). The FDA issued a Cleared decision on April 8, 2009, 187 days after receiving the submission on October 3, 2008. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5100.

Submission Details

510(k) Number K082951 FDA.gov
FDA Decision Cleared SESE
Date Received October 03, 2008
Decision Date April 08, 2009
Days to Decision 187 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement

Device Classification

Product Code ILJ — Bath, Hydro-massage
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5100