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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 K022674
Device Name BIRD AVEA VENTILATOR
Applicant
BIRD PRODUCTS CORP.
555 THIRTEENTH STREET, NW
WASHINGTON,  DC  20004 -1109
Applicant Contact JEFFREY K SHAPIRO
Correspondent
BIRD PRODUCTS CORP.
555 THIRTEENTH STREET, NW
WASHINGTON,  DC  20004 -1109
Correspondent Contact JEFFREY K SHAPIRO
Regulation Number868.5895
Classification Product Code
CBK  
Date Received08/12/2002
Decision Date 11/06/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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