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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 K921387
Device Name BIRD 8400ST ADULT VOLUME VENTILATOR
Original Applicant
BIRD PRODUCTS CORP.
1100 bird center dr.
palm springs,  CA  92262
Original Contact w. c bentinck
Regulation Number868.5895
Classification Product Code
CBK  
Date Received03/23/1992
Decision Date 03/11/1993
Decision substantially equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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