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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
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