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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 K990177
Device Name NELLCOR PURITAN BENNETT ACHIEVA VENTILATOR AND REPORT GENERATOR
Applicant
NELLCOR PURITAN BENNETT, INC.
2800 NORTHWEST BLVD.
MINNEAPOLIS,  MN  55441 -2625
Applicant Contact CHERYL ROSENBERG
Correspondent
NELLCOR PURITAN BENNETT, INC.
2800 NORTHWEST BLVD.
MINNEAPOLIS,  MN  55441 -2625
Correspondent Contact CHERYL ROSENBERG
Regulation Number868.5895
Classification Product Code
CBK  
Date Received01/19/1999
Decision Date 11/18/1999
Decision SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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