Cleared Abbreviated

AUTO THERM 390, MODEL ME 390

K042554 · Mettler Electronics Corp. · Physical Medicine

Oct 2004

Decision

18d

Days

Class 2

Risk

About This 510(k) Submission

K042554 is an FDA 510(k) clearance for the AUTO THERM 390, MODEL ME 390, a Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat (Class II — Special Controls, product code IMJ), submitted by Mettler Electronics Corp. (Anaheim, US). The FDA issued a Cleared decision on October 8, 2004, 18 days after receiving the submission on September 20, 2004. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5290.

Submission Details

510(k) Number	K042554 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 20, 2004
Decision Date	October 08, 2004
Days to Decision	18 days
Submission Type	Abbreviated
Review Panel	Physical Medicine (PM)
Summary	Summary PDF

Device Classification

Product Code	IMJ — Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 890.5290