Cleared Abbreviated

PARKER 500

K110994 · Arjohuntleigh, Inc. · Physical Medicine
Jul 2011
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K110994 is an FDA 510(k) clearance for the PARKER 500, a Bath, Hydro-massage (Class II — Special Controls, product code ILJ), submitted by Arjohuntleigh, Inc. (Addison, US). The FDA issued a Cleared decision on July 6, 2011, 89 days after receiving the submission on April 8, 2011. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5100.

Submission Details

510(k) Number K110994 FDA.gov
FDA Decision Cleared SESE
Date Received April 08, 2011
Decision Date July 06, 2011
Days to Decision 89 days
Submission Type Abbreviated
Review Panel Physical Medicine (PM)
Summary Summary PDF

Device Classification

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

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