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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 K073069
Device Name MODIFICATION TO AVEA VENTILATOR
Applicant
VIASYS RESPIRATORY CARE INC
1100 BIRD CENTER DR.
PALM SPRINGS,  CA  92262
Applicant Contact TOM GUTIERREZ
Correspondent
VIASYS RESPIRATORY CARE INC
1100 BIRD CENTER DR.
PALM SPRINGS,  CA  92262
Correspondent Contact TOM GUTIERREZ
Regulation Number868.5895
Classification Product Code
CBK  
Date Received10/30/2007
Decision Date 01/25/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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