Cleared Traditional

SONICATOR PLUS 992, MODEL NUMBER ME 992 AND SONICATOR PLUS 994, MODEL NUMBER ME 994

K984142 · Mettler Electronics Corp. · Physical Medicine

Feb 1999

Decision

83d

Days

Class 2

Risk

About This 510(k) Submission

K984142 is an FDA 510(k) clearance for the SONICATOR PLUS 992, MODEL NUMBER ME 992 AND SONICATOR PLUS 994, MODEL NUMBER ME 994, a Stimulator, Muscle, Powered (Class II — Special Controls, product code IPF), submitted by Mettler Electronics Corp. (Anaheim, US). The FDA issued a Cleared decision on February 9, 1999, 83 days after receiving the submission on November 18, 1998. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5850.

Submission Details

510(k) Number	K984142 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 18, 1998
Decision Date	February 09, 1999
Days to Decision	83 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Statement