Cleared Traditional

SONICATOR 716

K934846 · Mettler Electronics Corp. · Physical Medicine

Mar 1994

Decision

166d

Days

Class 2

Risk

About This 510(k) Submission

K934846 is an FDA 510(k) clearance for the SONICATOR 716, 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 March 23, 1994, 166 days after receiving the submission on October 8, 1993. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5860.

Submission Details

510(k) Number	K934846 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 08, 1993
Decision Date	March 23, 1994
Days to Decision	166 days
Submission Type	Traditional
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