Cleared Abbreviated

SONICATOR PLUS 940, MODEL ME940

K071137 · Mettler Electronics Corp. · Physical Medicine

Aug 2007

Decision

99d

Days

Class 2

Risk

About This 510(k) Submission

K071137 is an FDA 510(k) clearance for the SONICATOR PLUS 940, MODEL ME940, a Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat (Class II — Special Controls, product code IMG), submitted by Mettler Electronics Corp. (Anaheim, US). The FDA issued a Cleared decision on August 1, 2007, 99 days after receiving the submission on April 24, 2007. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5860.

Submission Details

510(k) Number	K071137 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 24, 2007
Decision Date	August 01, 2007
Days to Decision	99 days
Submission Type	Abbreviated
Review Panel	Physical Medicine (PM)
Summary	Summary PDF

Device Classification

Product Code	IMG — Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 890.5860