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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
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