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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 K080149
Device Name HEATER BASE, MODEL PMH7000
Applicant
Pacific Medico Co., Ltd.
2-6-4hongo, Bunkyo-Ku,
Tokyo,  JP 113-0033
Applicant Contact YOSHIMO TOYAMA
Correspondent
Pacific Medico Co., Ltd.
2-6-4hongo, Bunkyo-Ku,
Tokyo,  JP 113-0033
Correspondent Contact YOSHIMO TOYAMA
Regulation Number868.5450
Classification Product Code
BTT  
Date Received01/22/2008
Decision Date 12/18/2008
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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