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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Humidifier, Non-Direct Patient Interface (Home-Use)
510(k) Number K915603
Device Name VIROTHERM HUMIDIFIER
Applicant
Virotherm Laboratory
13485 Old Oak Way
Saratoga,  CA  95070
Applicant Contact WILLIAM PERETTI
Correspondent
Virotherm Laboratory
13485 Old Oak Way
Saratoga,  CA  95070
Correspondent Contact WILLIAM PERETTI
Regulation Number868.5460
Classification Product Code
KFZ  
Date Received12/16/1991
Decision Date 10/22/1992
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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