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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ventilator, non-continuous (respirator)
510(k) Number K863746
Device Name BIRD NIGHTBIRD NASAL CPAP SYSTEM
Applicant
BIRD PRODUCTS CORP.
1100 BIRD CENTER DR.
PALM SPRINGS,  CA  92262
Applicant Contact WILLIAM C BENTINCK
Correspondent
BIRD PRODUCTS CORP.
1100 BIRD CENTER DR.
PALM SPRINGS,  CA  92262
Correspondent Contact WILLIAM C BENTINCK
Regulation Number868.5905
Classification Product Code
BZD  
Date Received09/24/1986
Decision Date 12/15/1986
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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