Cleared Abbreviated

SONICATOR 740, MODEL ME 740

K053546 · Mettler Electronics Corp. · Physical Medicine

May 2006

Decision

135d

Days

Class 2

Risk

About This 510(k) Submission

K053546 is an FDA 510(k) clearance for the SONICATOR 740, MODEL ME 740, a Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat (Class II — Special Controls, product code IMI), submitted by Mettler Electronics Corp. (Anaheim, US). The FDA issued a Cleared decision on May 4, 2006, 135 days after receiving the submission on December 20, 2005. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5300.

Submission Details

510(k) Number	K053546 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 20, 2005
Decision Date	May 04, 2006
Days to Decision	135 days
Submission Type	Abbreviated
Review Panel	Physical Medicine (PM)
Summary	Summary PDF

Device Classification

Product Code	IMI — Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 890.5300