GEODESICEEG SYSTEM 400 SERIES (GES 400)— 510(k) K131882
Substantially EquivalentElectrical Geodesics, Inc.
FDA 510(k) clearance K131882 for GEODESICEEG SYSTEM 400 SERIES (GES 400), Substantially Equivalent on 2014-02-12. Applicant: Electrical Geodesics, Inc.. Device class: 2.
Clearance details
- Applicant
- Electrical Geodesics, Inc.
- Product code
- Code OLT
- Device class
- Class 2
- Regulation
- 21 CFR 882.1400
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Eugene, OR, US
Recent devices under product code OLT
view allMore clearances from Electrical Geodesics, Inc.
view allAdverse events under product code OLT
product code OLT- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K131882
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K131882.
Data sourced from openFDA. This site is unofficial and independent of the FDA.