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FDA 510(k), K123079, OLYMPIC BRAINZ MONITOR
FDA 510(k), K123079, OLYMPIC BRAINZ MONITOR
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510(K) Number: K123079
Device Name: OLYMPIC BRAINZ MONITOR
Manufacturer: EXCEL-TECH LTD. (XLTEK)
Device Classification Name: Amplitude-Integrated Electroencephalograph
Regulation Number: 882.1400
Classification Product Code: OMA
Date Received: 10/01/2012
Decision Date: 05/08/2013
Regulation Medical Specialty: Neurology
Device Name: OLYMPIC BRAINZ MONITOR
Manufacturer: EXCEL-TECH LTD. (XLTEK)
Device Classification Name: Amplitude-Integrated Electroencephalograph
Regulation Number: 882.1400
Classification Product Code: OMA
Date Received: 10/01/2012
Decision Date: 05/08/2013
Regulation Medical Specialty: Neurology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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