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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 K984535
Device Name PURITAN-BENNETT 840 VENTILATORY SYSTEM WITH BILEVEL OPTION
Applicant
PURITAN BENNETT CORP.
2200 FARADAY AVE.
CARLSBAD,  CA  92008
Applicant Contact ANN-MARIE BUTLER
Correspondent
PURITAN BENNETT CORP.
2200 FARADAY AVE.
CARLSBAD,  CA  92008
Correspondent Contact ANN-MARIE BUTLER
Regulation Number868.5895
Classification Product Code
CBK  
Date Received12/21/1998
Decision Date 12/28/1998
Decision SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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