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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Humidifier, Respiratory Gas, (Direct Patient Interface)
510(k) Number K936000
Device Name PURITAN-BENNETT CASCADE I SERIES HUMIDIFIER MODIFICATION
Applicant
Puritan Bennett Corp.
2200 Faraday Ave.
Carlsbad,  CA  92008
Applicant Contact ANN-MARIE BUTLER
Correspondent
Puritan Bennett Corp.
2200 Faraday Ave.
Carlsbad,  CA  92008
Correspondent Contact ANN-MARIE BUTLER
Regulation Number868.5450
Classification Product Code
BTT  
Date Received12/15/1993
Decision Date 08/15/1994
Decision Substantially Equivalent (SESE)
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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