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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Continuous, Facility Use
510(k) Number K162877
Device Name VOCSN Unified Respiratory System
Applicant
Ventec Life Systems, Inc.
19021 120th Ave. NE
Suite 101
Bothell,  WA  98011
Applicant Contact Joseph Cipollone
Correspondent
Ventec Life Systems, Inc.
19021 120th Ave. NE
Suite 101
Bothell,  WA  98011
Correspondent Contact Joseph Cipollone
Regulation Number868.5895
Classification Product Code
CBK  
Subsequent Product Codes
BTA   BZE   CAH   CAW   NHJ  
NOU  
Date Received10/14/2016
Decision Date 04/07/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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