Cleared Traditional

SYS*STIM 208 AND 208A

K031017 · Mettler Electronics Corp. · Physical Medicine

May 2003

Decision

60d

Days

Class 2

Risk

About This 510(k) Submission

K031017 is an FDA 510(k) clearance for the SYS*STIM 208 AND 208A, 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 May 30, 2003, 60 days after receiving the submission on March 31, 2003. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5850.

Submission Details

510(k) Number	K031017 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 31, 2003
Decision Date	May 30, 2003
Days to Decision	60 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF