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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 Classification Name active noise attenuation system for infant incubators
De Novo Number DEN220048
Device Name Neoasis
Requester
invictus medical, inc.
16601 blanco rd., suite 120
san antonio,  TX  78232
Contact george hutchinson
Regulation Number880.5405
Classification Product Code
QWX  
Date Received07/25/2022
Decision Date 06/16/2023
Decision granted (DENG)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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