EPIDURAL PEG ELECTRODE (EP), SPHENOIDAL ELECTRODE (EDS) AND FORAMEN, OVALE DEPTH ELECTRODE (ED-FO) FOR EPILEPSY MONITORI— 510(k) K961942
Substantially EquivalentRadionics, Inc.
FDA 510(k) clearance K961942 for EPIDURAL PEG ELECTRODE (EP), SPHENOIDAL ELECTRODE (EDS) AND FORAMEN, OVALE DEPTH ELECTRODE (ED-FO) FOR EPILEPSY MONITORI, Substantially Equivalent on 1997-08-18. Applicant: Radionics, Inc.. Device class: 2.
Clearance details
- Applicant
- Radionics, Inc.
- Product code
- Code GYC
- Device class
- Class 2
- Regulation
- 21 CFR 882.1310
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Burlington, MA, US
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