Cleared Abbreviated

MTD 4000

K091540 · Mettler Electronics Corp. · Physical Medicine
Oct 2009
Decision
135d
Days
Class 2
Risk

About This 510(k) Submission

K091540 is an FDA 510(k) clearance for the MTD 4000, a Equipment, Traction, Powered (Class II — Special Controls, product code ITH), submitted by Mettler Electronics Corp. (Anaheim, US). The FDA issued a Cleared decision on October 8, 2009, 135 days after receiving the submission on May 26, 2009. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5900.

Submission Details

510(k) Number K091540 FDA.gov
FDA Decision Cleared SESE
Date Received May 26, 2009
Decision Date October 08, 2009
Days to Decision 135 days
Submission Type Abbreviated
Review Panel Physical Medicine (PM)
Summary Summary PDF

Device Classification

Product Code ITH — Equipment, Traction, Powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5900

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