Cleared Traditional

SYS*STIM 207A

K893879 · Mettler Electronics Corp. · Physical Medicine
Dec 1989
Decision
207d
Days
Class 2
Risk

About This 510(k) Submission

K893879 is an FDA 510(k) clearance for the SYS*STIM 207A, 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 December 19, 1989, 207 days after receiving the submission on May 26, 1989. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5850.

Submission Details

510(k) Number K893879 FDA.gov
FDA Decision Cleared SESE
Date Received May 26, 1989
Decision Date December 19, 1989
Days to Decision 207 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary —

Device Classification

Product Code IPF — Stimulator, Muscle, Powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5850