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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 K001646
Device Name PURITAN-BENNETT 840 VENTILATOR SYSTEM WITH NEOMODE OPTION
Applicant
PURITAN BENNETT CORP.
2200 FARADAY AVE.
CARLSBAD,  CA  92008
Applicant Contact MARY E FUNK
Correspondent
PURITAN BENNETT CORP.
2200 FARADAY AVE.
CARLSBAD,  CA  92008
Correspondent Contact MARY E FUNK
Regulation Number868.5895
Classification Product Code
CBK  
Date Received05/30/2000
Decision Date 10/20/2000
Decision SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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