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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 K131388
Device Name TRANSCEND HEATED HUMIDIFIER
Applicant
SOMNETICS INTERNATIONAL, INC.
33 5TH AVE NW, STE 500
NEW BRIGHTON,  MN  55112
Applicant Contact MELINDA SWANSON
Correspondent
SOMNETICS INTERNATIONAL, INC.
33 5TH AVE NW, STE 500
NEW BRIGHTON,  MN  55112
Correspondent Contact MELINDA SWANSON
Regulation Number868.5450
Classification Product Code
BTT  
Date Received05/14/2013
Decision Date 09/26/2013
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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