Cleared Abbreviated

SONICATOR PLUS 930, MODEL ME 930

K013192 · Mettler Electronics Corp. · Physical Medicine

Oct 2001

Decision

22d

Days

Class 2

Risk

About This 510(k) Submission

K013192 is an FDA 510(k) clearance for the SONICATOR PLUS 930, MODEL ME 930, 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 October 17, 2001, 22 days after receiving the submission on September 25, 2001. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5300.

Submission Details

510(k) Number	K013192 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 25, 2001
Decision Date	October 17, 2001
Days to Decision	22 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