COLUMBIA 600 ELECTRODE, COLUMBIA 06 LEADWIRE
FDA 510(k) clearance K080386 · decided 2008-05-30
Clearance details
- K-number
- K080386
- Device name
- COLUMBIA 600 ELECTRODE, COLUMBIA 06 LEADWIRE
- Applicant
- Columbia Scientific Development, LLC
- Decision
- Substantially Equivalent
- Date received
- 2008-02-13
- Decision date
- 2008-05-30
- Days to decision
- 107 days
- Clearance type
- Traditional
- Product code
- GXY
- Device class
- 2
- Regulation number
- 882.1320
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Portland, OR, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.