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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 K070056
Device Name VAPOTHERM MODEL# 2000I AND 2000H
Applicant
Vapotherm, Inc.
555 Thirteenth St., NW
Washington,  DC  21666
Applicant Contact JOHNATHAN KAHAN
Correspondent
Vapotherm, Inc.
555 Thirteenth St., NW
Washington,  DC  21666
Correspondent Contact JOHNATHAN KAHAN
Regulation Number868.5450
Classification Product Code
BTT  
Date Received01/05/2007
Decision Date 04/13/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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