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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 K864173
Device Name HPD HUMIDIFYING CHAMBER
Applicant
Hpd Medical, Inc.
1000 Calle Negocio
San Clemente,  CA  92672 -6205
Applicant Contact C. P DUNLAP
Correspondent
Hpd Medical, Inc.
1000 Calle Negocio
San Clemente,  CA  92672 -6205
Correspondent Contact C. P DUNLAP
Regulation Number868.5450
Classification Product Code
BTT  
Date Received10/24/1986
Decision Date 01/30/1987
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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