Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative Grid Electrode, Dual-Sided Interhemispheric Subdural Electrode, Multi-Strip and Slit Grid Subdural Electrode, Intraoperative Mapping Grid Subdural Electrode— 510(k) K191186
Substantially EquivalentAd-Tech Medical Instrument Corporation
FDA 510(k) clearance K191186 for Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative Grid Electrode, Dual-Sided Interhemispheric Subdural Electrode, Multi-Strip and Slit Grid Subdural Electrode, Intraoperative Mapping Grid Subdural Electrode, Substantially Equivalent on 2020-01-25. Applicant: Ad-Tech Medical Instrument Corporation. Device class: 2.
Clearance details
- Applicant
- Ad-Tech Medical Instrument Corporation
- 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
- Oak Creek, WI, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.