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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 K120931
Model V8800
Device Name CRITICAL CARE VENTILATOR
Original Applicant
ORICARE, INC.
1900 am drive
quakertown,  PA  18951
Original Contact david jamison
Regulation Number868.5895
Classification Product Code
CBK  
Subsequent Product Codes
BTI   BTT   CCK  
Date Received03/27/2012
Decision Date 06/06/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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