Cleared Abbreviated

AUTO*THERM 395, MODEL ME 395

K022458 · Mettler Electronics Corp. · Physical Medicine

Sep 2002

Decision

62d

Days

Class 2

Risk

About This 510(k) Submission

K022458 is an FDA 510(k) clearance for the AUTO*THERM 395, MODEL ME 395, 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 September 26, 2002, 62 days after receiving the submission on July 26, 2002. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5290.

Submission Details

510(k) Number	K022458 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 26, 2002
Decision Date	September 26, 2002
Days to Decision	62 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