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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 K111640
Device Name PRECISION FLOW(R) - HELIOX
Applicant
Vapotherm, Inc.
198 Log Canoe Circle
Stevensville,  MD  21666
Applicant Contact GREGORY A WHITNEY
Correspondent
Vapotherm, Inc.
198 Log Canoe Circle
Stevensville,  MD  21666
Correspondent Contact GREGORY A WHITNEY
Regulation Number868.5450
Classification Product Code
BTT  
Date Received06/13/2011
Decision Date 10/07/2011
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
Recalls CDRH Recalls
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