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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 K983862
Device Name CLOUD 1 HUMIDIFICATION SYSTEM
Applicant
Respiratory Support Products, Inc.
2552 Mcgaw Ave.
Irvine,  CA  92614
Applicant Contact GORDON SHIGEZAWA
Correspondent
Respiratory Support Products, Inc.
2552 Mcgaw Ave.
Irvine,  CA  92614
Correspondent Contact GORDON SHIGEZAWA
Regulation Number868.5450
Classification Product Code
BTT  
Date Received11/02/1998
Decision Date 05/24/1999
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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