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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 K885314
Device Name HPD STERILE HUMIDIFYING CHAMBER
Applicant
Hpd Medical, Inc.
1000 Calle Negocio
San Clemente,  CA  92672
Applicant Contact DUNLAP
Correspondent
Hpd Medical, Inc.
1000 Calle Negocio
San Clemente,  CA  92672
Correspondent Contact DUNLAP
Regulation Number868.5450
Classification Product Code
BTT  
Date Received12/29/1988
Decision Date 01/17/1989
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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