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: KXA
Date Received: 03/10/2003
Decision Date: 10/10/2003
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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