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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 K203357
Device Name HVT 2.0
Applicant
Vapotherm, Inc.
100 Domain Dr.
Exeter,  NH  03833
Applicant Contact Dennis Francoeur
Correspondent
Vapotherm, Inc.
100 Domain Dr.
Exeter,  NH  03833
Correspondent Contact Dennis Francoeur
Regulation Number868.5450
Classification Product Code
BTT  
Date Received11/16/2020
Decision Date 08/25/2021
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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