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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 K970478
Device Name SCT 3000 HEATED HUMIDIFIER
Applicant
MARQUEST MEDICAL PRODUCTS, INC.
11039 EAST LANSING CIR.
ENGLEWOOD,  CO  80112
Applicant Contact THOMAS W DIELMANN
Correspondent
MARQUEST MEDICAL PRODUCTS, INC.
11039 EAST LANSING CIR.
ENGLEWOOD,  CO  80112
Correspondent Contact THOMAS W DIELMANN
Regulation Number868.5450
Classification Product Code
BTT  
Date Received02/07/1997
Decision Date 07/16/1997
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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