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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
510(k) Number K914994
Device Name HPD HEATER BASES
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 Number868.5270
Classification Product Code
BZE  
Date Received11/07/1991
Decision Date 02/12/1993
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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