TD50 Electromyograph
FDA 510(k) K935017 · Medelec Intl. Corp.
510(k) numberK935017
Submission
- Device name
- TD50 Electromyograph
- Applicant
- Medelec Intl. Corp.
England, GB - Received
- October 19, 1993
- Decision date
- July 28, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was TD50 Electromyograph cleared by the FDA?
TD50 Electromyograph (K935017) received a 510(k) decision of Substantially Equivalent on July 28, 1994, 282 days after the submission was received.
What is the product code of K935017?
The FDA product code is JXE – Device, Nerve Conduction Velocity Measurement, a Class II (moderate risk) device regulated under 21 CFR 882.1550.