Cleared Traditional

SYS STIM 294, MODEL ME 294

K984114 · Mettler Electronics Corp. · Physical Medicine

Feb 1999

Decision

84d

Days

Class 2

Risk

About This 510(k) Submission

K984114 is an FDA 510(k) clearance for the SYS STIM 294, MODEL ME 294, 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, 84 days after receiving the submission on November 17, 1998. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5850.

Submission Details

510(k) Number	K984114 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 17, 1998
Decision Date	February 09, 1999
Days to Decision	84 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Statement