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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 K852283
Device Name THERMIX INC. NASOTHERM II PERSONAL STEAM MACHINE
Applicant
THERMIX, INC.
6019 S. INGLESIDE AVE., SU 102
CHICAGO,  IL  60637
Applicant Contact DAVID G BOSTWICK
Correspondent
THERMIX, INC.
6019 S. INGLESIDE AVE., SU 102
CHICAGO,  IL  60637
Correspondent Contact DAVID G BOSTWICK
Regulation Number868.5460
Classification Product Code
KFZ  
Date Received05/29/1985
Decision Date 07/30/1985
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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