Evox Electro Diagnostic Device
FDA 510(k) K082614 · Laborie Medical Technologies, Inc.
510(k) numberK082614
Submission
- Device name
- Evox Electro Diagnostic Device
- Applicant
- Laborie Medical Technologies, Inc.
Williston, VT, US - Received
- September 9, 2008
- Decision date
- March 6, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Evox Electro Diagnostic Device cleared by the FDA?
Evox Electro Diagnostic Device (K082614) received a 510(k) decision of Substantially Equivalent on March 6, 2009, 178 days after the submission was received.
What is the product code of K082614?
The FDA product code is GWF – Stimulator, Electrical, Evoked Response, a Class II (moderate risk) device regulated under 21 CFR 882.1870.