Epidural Peg Electrode (Ep), Sphenoidal Electrode (Eds) and Foramen, Ovale Depth Electrode (Ed-Fo) for Epilepsy Monitori
FDA 510(k) K961942 · Radionics, Inc.
510(k) numberK961942
Submission
- Device name
- Epidural Peg Electrode (Ep), Sphenoidal Electrode (Eds) and Foramen, Ovale Depth Electrode (Ed-Fo) for Epilepsy Monitori
- Applicant
- Radionics, Inc.
Burlington, MA, US - Received
- May 20, 1996
- Decision date
- August 18, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Epidural Peg Electrode (Ep), Sphenoidal Electrode (Eds) and Foramen, Ovale Depth Electrode (Ed-Fo) for Epilepsy Monitori cleared by the FDA?
Epidural Peg Electrode (Ep), Sphenoidal Electrode (Eds) and Foramen, Ovale Depth Electrode (Ed-Fo) for Epilepsy Monitori (K961942) received a 510(k) decision of Substantially Equivalent on August 18, 1997, 455 days after the submission was received.
What is the product code of K961942?
The FDA product code is GYC – Electrode, Cortical, a Class II (moderate risk) device regulated under 21 CFR 882.1310.