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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 K020746
Device Name BIRD TBIRD VELA VENTILATOR
Applicant
BIRD PRODUCTS CORP.
1100 BIRD CENTER DR.
PALM SPRINGS,  CA  92262
Applicant Contact TOM GUTIERREZ
Correspondent
BIRD PRODUCTS CORP.
1100 BIRD CENTER DR.
PALM SPRINGS,  CA  92262
Correspondent Contact TOM GUTIERREZ
Regulation Number868.5895
Classification Product Code
CBK  
Date Received03/07/2002
Decision Date 04/22/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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