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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 K103316
Device Name FLOWREST
Applicant
Vapotherm, Inc.
198 Log Canoe Cir.
Stevensville,  MD  21666
Applicant Contact GREGORY A WHITNEY
Correspondent
Vapotherm, Inc.
198 Log Canoe Cir.
Stevensville,  MD  21666
Correspondent Contact GREGORY A WHITNEY
Regulation Number868.5450
Classification Product Code
BTT  
Date Received11/10/2010
Decision Date 02/08/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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