Evoport 100
FDA 510(k) K863985 · Jedmed Instrument Co.
510(k) numberK863985
Submission
- Device name
- Evoport 100
- Applicant
- Jedmed Instrument Co.
St. Louis, MO, US - Received
- October 14, 1986
- Decision date
- January 29, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Evoport 100 cleared by the FDA?
Evoport 100 (K863985) received a 510(k) decision of Substantially Equivalent on January 29, 1987, 107 days after the submission was received.
What is the product code of K863985?
The FDA product code is GWJ – Stimulator, Auditory, Evoked Response, a Class II (moderate risk) device regulated under 21 CFR 882.1900.