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FDA 510(k), K030737, OMEGA WHOLE-CORTEX MFG SYSTEM, MODELS OMEGA 151, OMEGA 275
FDA 510(k), K030737, OMEGA WHOLE-CORTEX MFG SYSTEM, MODELS OMEGA 151, OMEGA 275
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510(K) Number: K030737
Device Name: OMEGA WHOLE-CORTEX MFG SYSTEM, MODELS OMEGA 151, OMEGA 275
Manufacturer: DARYL WISDAHL
Device Classification Name: Source Localization Software For Electroencephalograph Or Magnetoencephalograph
Regulation Number: OLX
Classification Product Code: 03/10/2003
Date Received: 10/10/2003
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
Device Name: OMEGA WHOLE-CORTEX MFG SYSTEM, MODELS OMEGA 151, OMEGA 275
Manufacturer: DARYL WISDAHL
Device Classification Name: Source Localization Software For Electroencephalograph Or Magnetoencephalograph
Regulation Number: OLX
Classification Product Code: 03/10/2003
Date Received: 10/10/2003
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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