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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 K843932
Device Name VAPOR-PHASE HUMIDIFIER SYS-ADVANCED
Applicant
Inspiron Corp.
8600 Archibald Ave.
Rancho Cucamonga,  CA  91730
Applicant Contact THOMAS C BREWSTER
Correspondent
Inspiron Corp.
8600 Archibald Ave.
Rancho Cucamonga,  CA  91730
Correspondent Contact THOMAS C BREWSTER
Regulation Number868.5450
Classification Product Code
BTT  
Date Received10/05/1984
Decision Date 10/18/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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