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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 K981971
Device Name TBIRD VS/AVS VOLUME VENTILATOR, MODELS 15568, 15570 , LP10 VOLUME VENTILATOR WITH PRESSURE LIMIT MODEL 00-004130, BEAR 3
Applicant
BIRD PRODUCTS CORP.
1100 BIRD CENTER DR.
PALM SPRINGS,  CA  92262
Applicant Contact NEIL BATTISTE
Correspondent
BIRD PRODUCTS CORP.
1100 BIRD CENTER DR.
PALM SPRINGS,  CA  92262
Correspondent Contact NEIL BATTISTE
Regulation Number868.5895
Classification Product Code
CBK  
Date Received06/04/1998
Decision Date 08/24/1998
Decision SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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