Endodyne Dual
FDA 510(k) K840321 · Elmed, Inc.
510(k) numberK840321
Submission
- Device name
- Endodyne Dual
- Applicant
- Elmed, Inc.
Mchenry, IL, US - Received
- January 25, 1984
- Decision date
- March 16, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Endodyne Dual cleared by the FDA?
Endodyne Dual (K840321) received a 510(k) decision of Substantially Equivalent on March 16, 1984, 51 days after the submission was received.
What is the product code of K840321?
The FDA product code is LIH – Interferential Current Therapy, a Class II (moderate risk) device regulated under 21 CFR 882.5890.