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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Mechanical Ventilator
510(k) Number K152664
Device Name TAV System
Applicant
New Aera, Inc.
2400 Camino Ramon, Suite 365
Ramon,  CA  94583
Applicant Contact ERIC JOHANSSON
Correspondent
New Aera, Inc.
2400 Camino Ramon, Suite 365
Ramon,  CA  94583
Correspondent Contact PAUL DRYDEN
Regulation Number868.5895
Classification Product Code
ONZ  
Date Received09/17/2015
Decision Date 12/02/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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