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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 ventilator waveform analysis software
De Novo Number DEN250025
Device Name Syncron-E
Requester
autonomous healthcare, inc.
3080 olcott st., suite c210
santa clara,  CA  95054
Contact behnood gholami
Regulation Number868.5896
Classification Product Code
QVC  
Date Received06/23/2025
Decision Date 06/18/2026
Decision granted (DENG)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
Type Direct
Predetermined Change
Control Plan Authorized		 No
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