Cleared Traditional

SONICATOR 730

K943469 · Mettler Electronics Corp. · Physical Medicine

Aug 1994

Decision

41d

Days

Class 2

Risk

About This 510(k) Submission

K943469 is an FDA 510(k) clearance for the SONICATOR 730, 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 August 29, 1994, 41 days after receiving the submission on July 19, 1994. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5860.

Submission Details

510(k) Number	K943469 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 19, 1994
Decision Date	August 29, 1994
Days to Decision	41 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