Cleared Traditional

SONICATOR 720 (MODEL ME720)

K883228 · Mettler Electronics Corp. · Physical Medicine

Aug 1988

Decision

17d

Days

Class 2

Risk

About This 510(k) Submission

K883228 is an FDA 510(k) clearance for the SONICATOR 720 (MODEL ME720), 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 August 18, 1988, 17 days after receiving the submission on August 1, 1988. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5300.

Submission Details

510(k) Number	K883228 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 01, 1988
Decision Date	August 18, 1988
Days to Decision	17 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	—

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