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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 K013856
Device Name PMH 1000 HEATED HUMIDIFIER
Applicant
PEGASUS RESEARCH CORP.
1714 SOUTH LYON ST.
SANTA ANA,  CA  92705
Applicant Contact KENNETH G MILLER
Correspondent
PEGASUS RESEARCH CORP.
1714 SOUTH LYON ST.
SANTA ANA,  CA  92705
Correspondent Contact KENNETH G MILLER
Regulation Number868.5450
Classification Product Code
BTT  
Date Received11/06/2001
Decision Date 02/21/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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