MTD 4000
FDA 510(k) K091540 · Mettler Electronics Corp.
510(k) numberK091540
Submission
- Device name
- MTD 4000
- Applicant
- Mettler Electronics Corp.
Anaheim, CA, US - Received
- May 26, 2009
- Decision date
- October 8, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ITH – Equipment, Traction, Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5900
- Specialty
- Physical Medicine
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Questions and answers
When was MTD 4000 cleared by the FDA?
MTD 4000 (K091540) received a 510(k) decision of Substantially Equivalent on October 8, 2009, 135 days after the submission was received.
What is the product code of K091540?
The FDA product code is ITH – Equipment, Traction, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5900.