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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 K002686
Device Name ACHIEVA VENTILATOR Y-ACH+E, ACHIEVA PS VENTILATOR Y-ACHPS+E, ACHIEVA PSO2 VENTILATOR Y-ACHPS02+E
Applicant
Nellcor Puritan Bennett, Inc.
2800 Northwest Blvd.
Minneapolis,  MN  55441
Applicant Contact CHERYL NORTON
Correspondent
Nellcor Puritan Bennett, Inc.
2800 Northwest Blvd.
Minneapolis,  MN  55441
Correspondent Contact CHERYL NORTON
Regulation Number868.5895
Classification Product Code
CBK  
Date Received08/28/2000
Decision Date 10/18/2000
Decision SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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