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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 K013642
Device Name AVEA
Applicant
Bird Products Corp.
1100 Bird Center Dr.
Palm Spring,  CA  92262
Applicant Contact TOM GUTIERREZ
Correspondent
Bird Products Corp.
1100 Bird Center Dr.
Palm Spring,  CA  92262
Correspondent Contact TOM GUTIERREZ
Regulation Number868.5895
Classification Product Code
CBK  
Date Received11/05/2001
Decision Date 05/22/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
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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