STELLATE GRIDVIEW
FDA 510(k) clearance K100126 · decided 2010-12-03
Clearance details
- K-number
- K100126
- Device name
- STELLATE GRIDVIEW
- Applicant
- Excel-Tech Ltd. (Xltek)
- Decision
- Substantially Equivalent
- Date received
- 2010-01-19
- Decision date
- 2010-12-03
- Days to decision
- 318 days
- Clearance type
- Abbreviated
- Product code
- OLX
- Device class
- 2
- Regulation number
- 882.1400
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Oakville, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.