COLUMBIA 600 ELECTRODE, COLUMBIA 06 LEADWIRE— 510(k) K080386
Substantially EquivalentColumbia Scientific Development, LLC
FDA 510(k) clearance K080386 for COLUMBIA 600 ELECTRODE, COLUMBIA 06 LEADWIRE, Substantially Equivalent on 2008-05-30. Applicant: Columbia Scientific Development, LLC. Device class: 2.
Clearance details
- Applicant
- Columbia Scientific Development, LLC
- Product code
- Code GXY
- Device class
- Class 2
- Regulation
- 21 CFR 882.1320
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Portland, OR, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.