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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 K920002
Device Name MODEL 7200AE VENTILATOR FLOW BY 2.0 OR OPTION 50
Applicant
Puritan Bennett Corp.
2200 Faraday Ave.
Carlsbad,  CA  92008
Applicant Contact STEPHAN NORSTED
Correspondent
Puritan Bennett Corp.
2200 Faraday Ave.
Carlsbad,  CA  92008
Correspondent Contact STEPHAN NORSTED
Regulation Number868.5895
Classification Product Code
CBK  
Date Received01/02/1992
Decision Date 11/10/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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