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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name mixer, breathing gases, anesthesia inhalation
510(k) Number K973646
Device Name BIRD SENTRY BLENDER/ ANALYZER / BIRD SENTRY LOW FLOW BLENDER/ANALYZER
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 Number868.5330
Classification Product Code
BZR  
Date Received09/24/1997
Decision Date 05/07/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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