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FDA 510(k), K231914, Nurochek-II System
FDA 510(k), K231914, Nurochek-II System
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$49.00 USD
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$49.00 USD
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510(K) Number: K231914
Device Name: Nurochek-II System
Manufacturer: Adrian Cohen
Device Classification Name: Reduced- Montage Standard Electroencephalograph
Regulation Number: OMC
Classification Product Code: KXA
Date Received: 06/29/2023
Decision Date: 12/27/2023
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
Device Name: Nurochek-II System
Manufacturer: Adrian Cohen
Device Classification Name: Reduced- Montage Standard Electroencephalograph
Regulation Number: OMC
Classification Product Code: KXA
Date Received: 06/29/2023
Decision Date: 12/27/2023
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
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