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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 K922102
Device Name PROPORTIONAL SOLENOID VALVE
Applicant
Puritan Bennett Corp.
2200 Faraday Ave.
Carlsbad,  CA  92008
Applicant Contact LES HEINS
Correspondent
Puritan Bennett Corp.
2200 Faraday Ave.
Carlsbad,  CA  92008
Correspondent Contact LES HEINS
Regulation Number868.5895
Classification Product Code
CBK  
Date Received05/06/1992
Decision Date 09/15/1994
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
Predetermined Change
Control Plan Authorized		 No
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