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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 K894000
Device Name THERA-MIST HUMIDIFIER
Applicant
PEGASUS RESEARCH CORP.
3001 REDHILL AVE., SUITE 4-
119
COSTA MESA,  CA  92626
Applicant Contact KENNETH MILLER
Correspondent
PEGASUS RESEARCH CORP.
3001 REDHILL AVE., SUITE 4-
119
COSTA MESA,  CA  92626
Correspondent Contact KENNETH MILLER
Regulation Number868.5450
Classification Product Code
BTT  
Date Received06/05/1989
Decision Date 08/28/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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