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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Name: transcranial Decision Date To: 10/21/2026
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De Novo
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510(k)
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Decision
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Brainsway Deep Transcranial Magnetic Sti Brainways , Ltd. DEN170078 08/17/2018
NEURALIEVE CERENA TRANSCRANIAL MAGNETIC Eneura Therapeutics DEN130022 K130556 12/13/2013
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