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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 K923809
Device Name PURITAN-BENNETT MODEL 7200AE VENTILATOR
Applicant
Puritan Bennett Corp.
2200 Faraday Ave.
Carlsbad,  CA  92008
Applicant Contact MARK JENSEN
Correspondent
Puritan Bennett Corp.
2200 Faraday Ave.
Carlsbad,  CA  92008
Correspondent Contact MARK JENSEN
Regulation Number868.5895
Classification Product Code
CBK  
Date Received07/29/1992
Decision Date 10/27/1992
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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