Cleared Traditional

SONICATOR 710 (MODEL ME710)

K880901 · Mettler Electronics Corp. · Physical Medicine

Mar 1988

Decision

15d

Days

Class 2

Risk

About This 510(k) Submission

K880901 is an FDA 510(k) clearance for the SONICATOR 710 (MODEL ME710), 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 March 17, 1988, 15 days after receiving the submission on March 2, 1988. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5300.

Submission Details

510(k) Number	K880901 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 02, 1988
Decision Date	March 17, 1988
Days to Decision	15 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