Cleared Traditional

MODIFIED SONICATOR 720, MODEL ME720

K880602 · Mettler Electronics Corp. · Physical Medicine

Feb 1988

Decision

14d

Days

Class 2

Risk

About This 510(k) Submission

K880602 is an FDA 510(k) clearance for the MODIFIED 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 February 25, 1988, 14 days after receiving the submission on February 11, 1988. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5300.

Submission Details

510(k) Number	K880602 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 11, 1988
Decision Date	February 25, 1988
Days to Decision	14 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