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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nebulizer (Direct Patient Interface)
510(k) Number K220869
Device Name Vapotherm Aerosol Adapter AAA-2
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 Number868.5630
Classification Product Code
CAF  
Date Received03/25/2022
Decision Date 10/28/2022
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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