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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name High Flow/High Velocity Humidified Oxygen Delivery Device
510(k) Number K221318
Device Name HVT 2.0
Applicant
Vapotherm, Inc.
100 Domain Dr.
Exeter,  NH  03833
Applicant Contact Michael J. Webb
Correspondent
Vapotherm, Inc.
100 Domain Dr.
Exeter,  NH  03833
Correspondent Contact Michael J. Webb
Regulation Number868.5454
Classification Product Code
QAV  
Date Received05/06/2022
Decision Date 12/13/2022
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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